MULTICHEM A1c

04V0610 Bi-Level 2 x 6 x 1mL A1108180 2020-07-31

(HB001X) Level : 1 6x 1mL Level 1: A1108181

(HB002X) Level : 2 6 x 1mL Level 2: A1108182

INSTRUCTIONS FOR USE

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INTENDED USE
Multichem A1c control is intended for use as an assayed quality control material to monitor the precision of
laboratory testing procedures for the analyte, HbA1c as listed in the package insert.
SUMMARY AND PRINCIPLE
The use of quality control material is indicated as an objective assessment of the precision of methods and
techniques and is an integral part of good laboratory practices. Two levels of control are available to allow
performance monitoring within the clinical range.
COMPOSITION
This product is prepared from human whole blood to which stabilizers have been added. The control is used in
liquid form for convenience.
PRECAUTIONS
Warning: Biological source material. Treat as potentially infectious.
1. For In Vitro Diagnostic Use.
2. Each blood donor unit used in the preparation of this material was tested by United States Food and Drug
Administration (FDA) approved methods and found to be negative for antibodies to HIV and HCV, and non-reactive
for HBsAg. Because no test method can offer complete assurance that HIV, hepatitis B virus and hepatitis C virus
or other infectious agents are absent, this material should be handled as though capable of transmitting infectious
diseases.
3. This product may also contain other human source material for which there is no approved test. It is
recommended that this material be handled in accordance with the OSHA Standard on Bloodborne pathogens1,
Biosafety Level 22 or other appropriate biosafety practices3.
4. Dispose of any discarded materials in accordance with the requirements of your local waste management
authorities.
5. Material Safety Data Sheet (MSDS) is available for professional user on request.
PROCEDURE FOR USE
This product should be treated the same as patient specimens and run in accordance with the instructions
accompanying the instrument, kit or reagent being used. Frozen Control should be thawed at 2 to 8°C. Mix by
gentle inversion several times prior to use. Remove the cap before use. Replace the cap after use and return to 2
to 8°C storage immediately. Prior to subsequent use, remove from 2 to 8°C storage and mix by gentle inversion
several times before use. Do not shake vigorously.
In the event of damage to packaging, contact Abbott Customer Service.
STORAGE AND STABILITY
This product will be stable until the expiration date when stored unopened between -20°C and -80°C. For optimum
performance, avoid storage in a frost-free freezer or in a freezer which is opened regularly for other applications
such as storage of clinical samples. Once the control material is thawed and opened, it should be stored tightly
capped at 2 to 8°C. HbA1c is stable for 30 days under these conditions.
No exceptions apply to this lot.
LIMITATIONS
1. Do not use the product past the expiration date.
2. If there is evidence of microbial contamination or excessive turbidity in the product, discard the vial.
3. This product is not intended for use as a standard or calibrator.
4. If aliquoting this product, please follow the thawing and mixing procedure as outlined in the ‘Procedure for
Use’. Aliquot for single use and freeze immediately and use within 30 days .
ASSIGNMENT OF VALUES
The values provided in the data sheet were derived from replicate analyses and are specific for a particular lot of
product. These values have been generated using third party manufacturers’ instrument systems and are specific
to one measurement procedure. Technopath make no accuracy claims regarding these values. Tests were
performed by the control manufacturer and/or by independent laboratories, for various methods and instrument
systems. As a tool to assist in establishing their own mean, laboratories can import the values into their
instrument specific system. For more details and to register for access to this file please visit [Link].
com.
Values are provided only as guidelines, each laboratory should establish its own statistical limits. Laboratory
means may vary from the values listed during the shelf life of the control. Technopath monitors the values over the
shelf life of the control and provides update(s) at [Link] or contact your local Abbott customer
service representative.

BIBLIOGRAPHY
1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part 1910.1030, Bloodborne
pathogens.
2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. 5th
ed. Washington, DC: US Government Printing Office; December 2009.
3. World Health Organisation. Laboratory Biosafety Manual. 3rd ed. Geneva: World Health Organisation; 2004.
Customer Service: For questions, including suspected shipping damage, contact your local area Abbott Customer
Service representative or find country specific contact information at [Link].

Techno-path Manufacturing Ltd, Fort Henry Business Park, Ballina, Co. Tipperary, Ireland. Distributed by
Ph: +353 (0) 61 525700 Web: [Link] Abbott Laboratories Inc, Abbott Park, IL 60064 USA and ABBOTT 65205 Wiesbaden, Germany
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GLOSSARY
ANALYTES (Value Assigned)
HbA1c

TERMS
Mean
Range
Units
Level
Data Sheet
Bi-Level

Techno-path Manufacturing Ltd, Fort Henry Business Park, Ballina, Co. Tipperary, Ireland. Distributed by
Ph: +353 (0) 61 525700 Web: [Link] Abbott Laboratories Inc, Abbott Park, IL 60064 USA andABBOTT 65205 Wiesbaden, Germany
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Abbott Chemistry Systems LEVEL 1 LEVEL 2 LEVEL 1 LEVEL 2
Mean Range Mean Range Mean Range Mean Range
ANALYTES ARCHITECT ALINITY NGSP UNITS IFCC UNITS

HbA1c {4P52} {08P43} (%) 5.30 4.77 - 5.83 11.3 10.2 - 12.4 mmol/mol 34.5 28.7 - 40.3 99.8 87.5 - 112

Techno-path Manufacturing Ltd, Fort Henry Business Park, Ballina, Co. Tipperary, Ireland. Distributed by
Ph: +353 (0) 61 525700 Web: [Link] Abbott Laboratories Inc, Abbott Park, IL 60064 USA andABBOTT 65205 Wiesbaden, Germany
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Footnotes
1. ARCHITECT and Alinity are a trademark of Abbott Laboratories in various jurisdictions.
2. Some of the assays listed may not be available in all countries.
3. Value assignment is performed using the ARCHITECT list numbers which have been shown to be equilivant to the Alinity list numbers and are considered family
members.
■ Values are not provided.

Techno-path Manufacturing Ltd, Fort Henry Business Park, Ballina, Co. Tipperary, Ireland. Distributed by
Ph: +353 (0) 61 525700 Web: [Link] Abbott Laboratories Inc, Abbott Park, IL 60064 USA and ABBOTT 65205 Wiesbaden, Germany

a
Control
h M
Catalog Number Manufacturer
H
Use By (yyyy-MM-DD)
g
Lot Number
V
In Vitro Diagnostic Medical
i
Consult Instructions for Use
F
Biological Risks
l
Temperature Limitation
Device

f INFORMATION FOR USA ONLY DISTRIBUTED BY PRODUCT OF IRELAND GTIN

Serial Number Information needed for United States of America only Distributed By Product of Ireland Global Trade Item Number

ENIFU-QP-83.01-A11.01

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