McKesson TRUEresult User manual

QUALITY ASSURANCE AND
QUALITY CONTROL REFERENCE GUIDE
FOR MULTI-PATIENT USE FACILITIES
QUALITY ASSURANCE AND
QUALITY CONTROL REFERENCE GUIDE
FOR MULTI-PATIENT USE FACILITIES
Information in This Manual is Spe ifi for Health are Providers
ATTENTION:
TRUEtest™Strips ontain GDH-PQQ
enzyme. Please arefully review all riti al
safety information and instru tional
materials prior to performing patient
blood glu ose testing.
ATTENTION: RISK MANAGEMENT AND CHIEF MEDICAL OFFICER
www.ho ediagnostics.co
1-800-803-6025 or 1-954-677-4599.
© 2010 Home Diagno tic , Inc. TRUEre ult and TRUEte t are trademark of Home Diagno tic , Inc. E9SUN21 Rev. 3 • E9051-90

QUALITY ASSURANCE AND
QUALITY CONTROL REFERENCE GUIDE
FOR MULTI-PATIENT USE FACILITIES

TRUEresult®Quality Assurance / Quality Control Manual
1
Safety Notice
ATTENT ON: Pharmacy Staff, Nursing Staff, Laboratory Staff, and
Central Supply Staff – Reminder of Potential for Falsely
Elevated Blood Glucose Results due to Drug nterferences
This Safety Notice is for personnel involved in the issuance of point-of-care
blood glucose testing systems and personnel involved in actual point-of-care
blood glucose testing. Parenterally administered drugs containing or
metabolizing to maltose or galactose, and orally administered xylose can cause
falsely high blood glucose results with certain point-of-care blood glucose
monitoring systems that utilize the enzyme glucose dehydrogenase-PQQ
(G H-PQQ) for the measuring of a blood glucose result.
Please note: The interferences described in this Notice may be seen with all
blood glucose monitoring systems that use GDH-PQQ methodology, regardless
of the manufacturer of the system.
The information regarding the limitations of using G H-PQQ methodology may
or may not be included in the labeling of drugs containing or metabolizing
maltose, galactose, or xylose. It is important that all staff are aware of this
interference in order to prevent inappropriate treatment based on falsely elevated
blood glucose results. Staff must advise at-risk patients who use blood glucose
monitoring systems with G H-PQQ methodology of these risks and the
consequences of inappropriate treatment.
Who is at risk?
Patients at risk for falsely elevated blood glucose results include those using
blood glucose monitoring systems utilizing glucose dehydrogenase-PQQ, and
who are:
• Peritoneal dialysis patients receiving dialysis solutions containing
icodextrin (e.g. Extraneal®, Icodial®) that is metabolized to maltose;
• Receiving injections or infusions of solutions containing galactose or
maltose (including some human immunoglobulin preparations
(e.g. Octagam®, WinRho®, S F Liquid, HepaGam B™);
• Patients undergoing xylose absorption testing;
• Patients receiving intravenous solutions containing maltose as a
substitute for glucose or as a means for patient hydration;
• Patients receiving any drugs, including any investigational drugs and
those made by compounding pharmacies, which contain or metabolize
to maltose, galactose, or xylose (Orencia®, Adept®, Bexxar®).
Note: An At- isk Patient Identification Notice located under Forms, Section
10, in this Manual may be used for easy identification of at-risk
patients.

Home Diagnostics, nc Blood Glucose Monitoring Systems Using GDH-PQQ
• TRUEresult®/ TRUEtest™ Blood Glucose Test Strips
• TRUE2go™ / TRUEtest™ Blood Glucose Test Strips
What causes these interferences?
The G H-PQQ methodology does not distinguish between maltose, galactose,
xylose, and glucose when measuring blood glucose. Maltose, galactose, and xylose
are not normally found in the blood, but can be found with the administration of
certain drugs. When present in the blood, these substances can falsely increase the
blood glucose result to a clinically significant level. A false high glucose result may
lead to in inappropriate treatment, such as the injection of insulin, which could lead
to a hypoglycemic coma and death.
Actions required:
• Be aware of the drugs used (including any investigational drugs and
those made by compounding pharmacies) that contain or metabolize
maltose, galactose, or xylose,
• At patient admission/presentation and periodically throughout the
patient’s stay at the facility, assess the presence and use of therapies
containing interfering drugs,
• Consult with the pharmacist for more information on which drugs have
been or will be administered to the patient,
• Identify and flag files or records of at-risk patients,
• If there are pre-print orders sets for patients receiving interfering drugs,
include a prescription to test blood glucose using laboratory methods,
• Use only laboratory methods for monitoring blood glucose levels in
patients receiving interfering drugs,
• Establish facility protocols to verify point-of-care (bedside) blood
glucose results with laboratory results for patients who are unresponsive
or unable to communicate,
• Ensure that protocols for testing adequately address the issue when the
patient history is unknown,
• If your facility provides a blood glucose monitoring system for use at
home for an at-risk patient, instruct the patient not to use a blood glucose
monitoring system that utilizes G H-PQQ, including the TRUE2go and
TRUEresult Systems,
• After drug treatment is completed, ensure that use of a blood glucose
monitoring system that utilizes G H-PQQ is cleared by the octor or
Healthcare Professional before use.
File this Safety Notice for future reference.
Questions?
If you have any questions regarding the information contained in this Safety
Notice, please go to
www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm. or
call for assistance using the number on the front cover of the Manual.
TRUEresult®Quality Assurance / Quality Control Manual
2

TRUEresult®Quality Assurance / Quality Control Manual
3
ntroduction
Home iagnostics, Inc (H I) is proud to present the TRUEresult Blood Glucose
Monitoring System, a no-coding system which means the Meter does not have to
be coded to each lot of test strips. The Quality Assurance/Quality Control
Manual is designed for use specifically by the Healthcare Professional for point-
of-care testing in a multi-patient, multi-user setting. Healthcare Professionals in
your facility now have a very simple and accurate way to safely test blood
glucose levels in your patients.
Home iagnostics, Inc. recognizes the importance of practicing safe and reliable
testing using the TRUEresult Blood Glucose Monitoring System. Therefore, this
Manual has been designed to provide the following:
• A basic understanding of the TRUEresult System,
• A detailed testing guide,
• Quality Control Program recommendations for the TRUEresult
System in your facility,
• A complete guide to troubleshooting issues and concerns that may
arise with using with the TRUEresult System in patient care,
• A comprehensive H I certified training program for Healthcare
Professionals that will be using the TRUEresult System.
CAUTION!
Please read this entire Manual and all product Instructions for Use before
testing. Operators of the T UEresult Blood Glucose Monitoring System must
be trained per the HD Training Certification Program, Section 9, prior to
using the product.
CAUTION!
DO NOT change patient medication, diet, or exercise routine without
consulting the patient’s Doctor or Diabetes Healthcare Professional.
Use of T UEresult in a manner not specified in this Manual is not
recommended and may affect the ability to determine true blood glucose levels.
Our goal is to provide quality healthcare products and dedicated customer
service. For questions about the TRUEresult products, visit our website at
www.homediagnostics.com.

TRUEresult®Quality Assurance / Quality Control Manual
4
Table of Contents
Safety Notice...........................................................................................................................................1-2
ntroduction ...............................................................................................................................................3
Table of Contents ......................................................................................................................................4
Section 1: Using TRUEresult®in a Clinical Setting
Critical Safety Information/Important Information/Limitations/Expected Results ....................6-8
Regulatory Requirements - CLIA...................................................................................................9
Proficiency Testing Information ...................................................................................................10
Meter Specifications .....................................................................................................................11
Material Safety ata Sheets (MS S)......................................................................................12-17
Section 2: Description of System
Meter........................................................................................................................................19-20
TRUEtest™ Test Strips ...........................................................................................................20-21
TRUEtest Glucose Control Solution.............................................................................................22
Section 3: Quality Control Testing
Automatic Self-Test ......................................................................................................................24
Control Test...................................................................................................................................24
How to Perform a Control Test ...............................................................................................25-26
Section 4: Blood Glucose Testing
Sample Information .................................................................................................................28-29
Obtaining a Blood Sample............................................................................................................29
Tips for Fingertip Sampling....................................................................................................29
Tips for Forearm Sampling ...............................................................................................29-30
How to Perform a Blood Test..................................................................................................30-31
System Out of Range Warning Messages ....................................................................................31
Section 5: Set Up of Time, Date, Ketone Alert and Testing Reminders
Time/ ate......................................................................................................................................33
Ketone Alert..................................................................................................................................34
Testing Reminders ...................................................................................................................34-35
Exit Set Up....................................................................................................................................35
Section 6: Memory
Memory, Viewing Averages, Viewing Memory.....................................................................37-38
Section 7: Care and Storage of System
System (Meter and Test Strips) ....................................................................................................40
Meter .............................................................................................................................................40
TRUEtest Test Strips ....................................................................................................................40
TRUEtest Glucose Control Solution.............................................................................................40
Battery Replacement .....................................................................................................................41
Section 8: Troubleshooting
isplay Messages..........................................................................................................................43
isplay Messages..........................................................................................................................44
Section 9: Training Certification Program
Certificate Information ............................................................................................................46-47
Training Checklist ...................................................................................................................48-49
Training Written Test ..............................................................................................................50-54
Training Certificate (example)......................................................................................................55
Section 10: Forms
Quality Control Log.................................................................................................................57-58
At-Risk Patient Identification Notice ...........................................................................................59
Section 11: TRUEresult Lifetime Warranty
TRUEresult Lifetime Warranty ....................................................................................................61
Section 12: References
References .....................................................................................................................................63

Section 1:
Using TRUEresult®
in a Clinical Setting

TRUEresult®Quality Assurance / Quality Control Manual
Critical Safety nformation / mportant nformation / Limitations /
Expected Results
WA NING!
T UEtest Blood Glucose Test Strips utilize glucose dehydrogenase-PQQ
(GDH-PQQ). The T UEresult System MUST NOT be used for the following
patient conditions:
• Peritoneal dialysis patients receiving dialysis solutions containing
icodextrin (e.g. Extraneal®, Icodial®) that is metabolized to
maltose,
• Injection or infusion of solutions containing galactose or maltose,
including some human immunoglobulin preparations
(e.g. Octagam®, Win ho®, SDF Liquid, HepaGam B™),
• Patients undergoing xylose absorption testing,
• Patients receiving intravenous solutions containing maltose as a
substitute for glucose or as a means for patient hydration,.
• Any drugs, including any investigational drugs and those made by
compounding pharmacies, which contain or metabolize to maltose,
galactose, or xylose (Orencia®, Adept®, Bexxar®).
Using the T UEresult System for testing patients with the above conditions
may result in falsely high glucose results. A falsely elevated glucose result may
cause a patient or healthcare professional to take inappropriate steps to bring
the blood glucose in normal range, including giving insulin. The inappropriate
use of insulin could lead to unconsciousness, severe hypoglycemic coma and
possible death. More information may be found in the T UEtest Test Strip
Instructions for Use or at
www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm1
Limitations
• Please read all product Instructions for Use carefully before
referencing or using this Manual.
• Use only TRUEtest Blood Glucose Test Strips and TRUEtest Glucose
Control Solution when testing with the TRUEresult Meter.
• Perform Glucose Control Tests before performing a blood glucose
test (See Quality Control Testing, Section 3), when using the System
for the first time. Three levels of TRUEtest Glucose Control Solution
are available for Quality Control Testing. Contact your distributor to
order different levels of Glucose Control Solution. We recommend
testing at least 2 levels of Control. For testing frequency and the
number of Control levels to test, refer to your facility quality control
procedure/policy.
• TRUEresult is an in vitro quantitative system that is used for self
testing and point-of-care testing of human whole blood only.
6

TRUEresult®Quality Assurance / Quality Control Manual
7
• The most accurate results are obtained using fresh, capillary whole
blood from the fingertip. Venous whole blood drawn in E TA
(purple top tube) or heparin (green top tube) may be used for testing.
Mix tube contents gently before using. Use venous blood within 30
minutes after drawing. Serum, clotted blood, or plasma cannot be
used with the TRUEresult System.
• Capillary blood from the forearm may be used. Check with the
octor or Healthcare Professional to see if forearm testing may be
used for glucose testing on the patient. Results from the forearm are
not always the same as results from the fingertip. Use fingertip
instead of forearm:
- Within 2 hours of eating, exercise, or taking insulin,
- If the patient’s blood glucose may be rising or falling rapidly or
their results often fluctuate,
- If the patient is ill or under stress,
- If the glucose result may be low or high,
- If symptoms of low or high glucose levels are not evident.2
• For evaluation or Quality Control procedures where TRUEresult
blood glucose values are compared to blood glucose values given by
a laboratory, it is recommended that capillary or venous whole blood
obtained from the same site be used for both the laboratory
instrument as well as the TRUEresult System. Laboratory tests should
be performed within 30 minutes of a blood glucose meter test to
minimize the changes in glucose values due to glycolysis. Results
from the TRUEresult System are considered accurate if within + 20%
of laboratory results. If patient has recently eaten, finger results
from the TRUEresult System can be up to 70 mg/dL higher than
venous laboratory results.3
• The TRUEresult System cannot be used in the diagnosis of diabetes
or to test blood glucose in neonates.
• Inaccurate results may occur in severely hypotensive patients or
patients in shock. Inaccurate results may occur for patients
experiencing a hyperglycemic-hyperosmolar state, with or without
ketosis. Critically ill patients should not be tested with a blood
glucose meter.4
• Testing at altitudes up to and including 10,150 feet will not affect
accurate results.5
• Hematocrit levels between 20% and 60% will not affect accurate
results.5

Expected Results
Each patient should have specific blood glucose target ranges that are
determined by the octor or iabetes Healthcare Professional. Having most
blood glucose results within the patient’s target range shows how well a
treatment plan is working to control glucose levels. Keeping results within the
patient’s target range helps slow or stop complications from diabetes.
Expected Results for people without diabetes6:
Plasma Blood Glucose Result
Before eating <126 mg/dL
Two hours after meals <200 mg/dL
• Low blood glucose (hypoglycemia) symptoms may include
trembling, sweating, intense hunger, nervousness, weakness or
trouble speaking.
• High blood glucose (hyperglycemia) symptoms may include intense
thirst, a need to urinate often, a dry mouth, vomiting, or headache.
If the patient is showing any of these symptoms, check their blood glucose. If
any result seems higher or lower than expected, repeat the test with a new Test
Strip. Contact the octor or iabetes Healthcare Professional with any unusual
results.
TRUEresult®Quality Assurance / Quality Control Manual
8

Regulatory Requirements - CL A
Self-testing and point-of-care testing of blood glucose has been classified by the
Clinical Laboratory Improvement Amendments (CLIA) as a waived test. CLIA
requires all entities that perform even one test, including waived tests, [on
materials derived for the human body for the purpose of providing information
for the diagnosis, prevention or treatment of any disease or impairment of, or the
assessment of the health of, human beings] to meet certain Federal requirements.
If an entity performs tests for these purposes, it is considered under CLIA to be a
laboratory and must register with the CLIA program.
Waived laboratories must meet the following requirements:
• Complete the Clinical Laboratory Improvement Amendments of 1988
(CLIA) Application for Certification, Form CMS-116. The form and
instructions on completing and mailing the form are found on
http://www.cms.hhs.gov/CLIA/06_How_to_Apply_for_a_CLIA_
Certificate_Including_Foreign_Laboratories.asp#TopOfPage.
• Pay applicable certificate fees biennially.
• Follow manufacturer’s test instructions, including instructions for
Quality Control, maintenance, and storage instructions.
Upon approval of Form CMS-116, a Certificate of Waiver is forwarded to the
laboratory.
For more information on the CLIA program, see http://www.cms.hhs.gov/CLIA/.
For a comprehensive look at waived testing, see
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm.
TRUEresult®Quality Assurance / Quality Control Manual
9

TRUEresult Blood Glucose Monitoring System
Proficiency Testing nformation
The objective of proficiency testing is to qualitatively determine the skill of the
user of a specific product and the accuracy of the results obtained using the
product. Participating laboratories receive specimens from a distributor, test the
specimens and report the results back to the distributor. The results of all
participants are summarized in a report that is sent to the participating
laboratories. The report contains an evaluation of the individual laboratory
performance as well as a comparison to a summary of results from other
participating labs.
It is important to be aware that proficiency samples are not fresh blood and may
behave differently on different glucose test systems. The accuracy of the result
from a proficiency sample is not an indicator of the accuracy of your system
when tested with fresh whole blood obtained from a patient. The proficiency
testing only serves to show how your results compare to other TRUEresult
system users. If your proficiency sample results are not within acceptable limits
of other TRUEresult users’ results, then you should investigate possible sources
of testing error such as expiration date and storage conditions for the test strips.
Always perform quality control testing per your facility’s procedures and
policies to make sure your system is working properly. The Owner’s Booklet or
QA Manual will assist you with this process.
The TRUEresult system is optimized to give accurate results with fresh, capillary
whole blood and venous whole blood samples. Venous whole blood samples
must be tested immediately or preserved in a vacutainer tube containing E TA
(purple top) or heparin (green top). This will preserve the sample for
approximately 30 minutes. Refer to the TRUEresult Owners Booklet and
TRUEtest Strip Instructions for Use for further information.
Resources to learn about and obtain Proficiency Samples:
College of American Pathology (CAP) www.cap.org
American Association of Bioanalysts www.aab.org
TRUEresult®Quality Assurance / Quality Control Manual
10

Meter Specifications
Result Range: 20 - 600 mg/dL
Sample Size: Minimum 0.5 microliters (0.5 µL)
Sample Type: Fresh capillary whole blood from the finger or forearm,
venous blood drawn in E TA (purple top tube) or heparin
(green top tube) within 30 minutes of collection
Test Time: As little as 4 seconds
Result Value: Plasma calibrated
Assay Method: Electrochemical
Reference Method: Yellow Springs Instrument (YSI)
Power Supply: One 3V lithium battery #CR2032 (non-rechargeable)
Total power when active at full battery = 8.6 mW
Battery Life: Approximately 2146 tests or 1.5 years
Automatic Shut-off: After 2 minutes of non-use
Weight: 1.66 ounces
Size: 3.44” x 2.16” x 0.69”
Memory Size: 500 results
System Operating Range (Meter and Test Strips):
Relative Humidity: 10 - 90% (non-condensing)
Temperature: 50° - 104°F
Hematocrit: 20 - 60%
Note: Use within specified environmental conditions only.
Chemical Composition
TRUEtest Test Strips: Glucose dehydrogenase - PQQ (Acinetobacter
calcoaceticus), mediators, buffers and stabilizers
TRUEtest Glucose Control Solution: Water, d-glucose, buffers,
viscosity enhancing agent, salts, dye and preservatives
TRUEresult®Quality Assurance / Quality Control Manual
11

Material Safety Data Sheet
Section 1 : Product nformation
Product Name : TRUEtest Blood Glucose Test Strips
Date Prepared : 16 April 2008
Revision Number : 0
Section 2 : Composition / nformation on ngredients
Vial: Silica Gel, polypropylene, polyethylene
Test Strips: Glucose dehydrogenase-PQQ, mediators, buffers and stabilizers
Test Strip Box and Package nsert: Paper
Section 3 : Hazard dentification
No significant immediate hazards for emergency response are known.
Section 4 : Emergency First Aid Procedures
Eye: No first aid required.
Skin: No first aid required for contact with skin.
ngestion: No first aid required from ingestion.
nhalation: No first aid required.
Section 5 : Fire and Explosion Hazard Data
Flash Point (Method Used): Vial - > 450°F (estimated), Test Strips - N/A
Flammable Limits: N/A
General Hazard: Solid material may burn at or above the flashpoint. If
thermally decomposed, flammable/toxic gases may be released. Toxic gases will
form upon combustion. Hazardous combustion products may include and are not
limited to: carbon monoxide, carbon dioxide.
Special Fire Fighting Procedures: Use water spray to cool fire exposed
surfaces and to protect personnel. Isolate “fuel” supply to fire. Extinguish the
fire by cooling with water spray. Respiratory and eye protection required for fire
fighting personnel.
Unusual Fire and Explosion Hazards: None determined.
TRUEresult®Quality Assurance / Quality Control Manual
12

Section 6 : Spill or Leak Procedures
Steps to be taken in case material is released or spilled: Contain material to
prevent contamination of soil, surface water and ground water. May be slipping
hazard.
Section 7 : Handling and Storage
Store at temperatures and conditions as indicated on the product label. Store in
original container and keep vial closed.
Section 8 : Personal Protection
Ventilation: Use general room ventilation.
Respiratory Equipment: None.
Protective Gloves: None
Eye Protection: None
Other Protective Equipment/Clothing: None
Section 9 : Physical Data
Appearance and odor: Vial - Vial with desiccant liner, Test Strips - Plastic
strip with reaction area.
pH: N/A
Specific Gravity: N/A
Boiling Point: N/A
Melting Point: N/A
Vapor Pressure: N/A
Evaporation Rate: N/A
Solubility in Water: N/A
Section 10 : Reactivity Data
Stability: Stable if at storage temperature and original vial closed.
Conditions to Avoid: Product can oxidize and decompose at elevated
temperatures. Avoid putting water inside of vial, exothermic reaction will occur.
Temperatures above 300°F may cause product degradation and self combustion.
Substances to Avoid: Avoid contact with strong acids and oxidizing materials.
Hazardous Decomposition Products: Flammable hydrocarbons.
Hazardous Polymerization: Will not occur.
TRUEresult®Quality Assurance / Quality Control Manual
13

Section 11 : Toxicological nformation
Chronic Effects of Overexposure: None currently known.
Carcinogen or Suspected Carcinogen: None of the compounds present are
listed as a carcinogen or suspected carcinogen.
Medical Conditions Aggravated by Exposure: None currently known.
Acute Toxicity Values: Not applicable.
Section 12 : Ecological nformation
Ecological effects of this product have not been determined.
Section 13 : Disposal
Primary Container Type: Vial with 50 test strips.
Waste Disposal Method: Each disposal facility must determine proper disposal
methods to comply with local, state, and federal environmental regulations.
TRUEresult®Quality Assurance / Quality Control Manual
14

Material Safety Data Sheet
Section 1 : Product nformation
Product Name : TRUEtest Glucose Control Solution - Levels 1, 2, and 3
Date Prepared : 16 April 2008
Revision Number : 0
Section 2 : Composition / nformation on ngredients
Bottle: Polypropylene, polyethylene
Control Solution: Water, d-glucose, buffers, viscosity enhancing agents, salts,
dyes, and preservatives.
Control Solution Box and Package nsert: Paper
Section 3 : Hazard dentification
No significant immediate hazards for emergency response are known.
Section 4 : Emergency First Aid Procedures
Eye: Flush with copious amounts of water
Skin: Flush with water
ngestion: Contact physician
nhalation: Contact physician
Section 5 : Fire and Explosion Hazard Data
Flash Point (Method Used): Bottle - N/A, Control Solution - N/A
Flammable Limits: N/A
General Hazard: N/A
Special Fire Fighting Procedures: N/A
Unusual Fire and Explosion Hazards: None determined.
Section 6 : Spill or Leak Procedures
Steps to be taken in case material is released or spilled: Contain material to
prevent contamination of soil, surface water and ground water. May be slipping
hazard.
TRUEresult®Quality Assurance / Quality Control Manual
15

Section 7 : Handling and Storage
Store at temperatures and conditions as indicated on the product label. Keep
bottle tightly closed when not in use.
Section 8 : Personal Protection
Ventilation: Use general room ventilation.
Respiratory Equipment: None.
Protective Gloves: None
Eye Protection: None
Other Protective Equipment/Clothing: None
Section 9 : Physical Data
Appearance and odor: Bottle - plastic bottle with cap, Control Solution - Red
liquid
pH: N/A
Specific Gravity: N/A
Boiling Point: N/A
Melting Point: N/A
Vapor Pressure: N/A
Evaporation Rate: N/A
Solubility in Water: N/A
Section 10 : Reactivity Data
Stability: Stable at storage temperature. Keep bottle closed when not in use.
Conditions to Avoid: N/A
Substances to Avoid: Avoid contact with strong acids and oxidizing materials.
Hazardous Decomposition Products: Flammable hydrocarbons.
Hazardous Polymerization: Will not occur.
Section 11 : Toxicological nformation
Chronic Effects of Overexposure: None currently known.
Carcinogen or Suspected Carcinogen: None of the compounds present greater
than 0.1% are listed as a carcinogen or suspected carcinogen.
Medical Conditions Aggravated by Exposure: None currently known.
Acute Toxicity Values: Not applicable.
TRUEresult®Quality Assurance / Quality Control Manual
16

Section 12 : Ecological nformation
Ecological effects of this product have not been determined.
Section 13 : Disposal
Primary Container Type: Bottle with 3 mL Glucose Control Solution.
Waste Disposal Method: Each disposal facility must determine proper disposal
methods to comply with local, state, and federal environmental regulations.
TRUEresult®Quality Assurance / Quality Control Manual
17

Section 2:
Description
of System