Product Manual

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For In Vitro Diagnostic Use
INTENDED USE
For use as an erythrocyte lytic reagent for the quantitative
determination of hemoglobin on COULTER A
C
•T 5diff
hematology analyzers. Intended for use only with specific
A
C
•T 5diff reagents. Refer to your instrument product
manuals and/or online help, as applicable.
SUMMARY
COULTER A
C
•T 5diff Hgb Lyse reagent is used as a lytic
agent to prepare a diluted whole blood sample for the
quantitative determination of hemoglobin.
PRINCIPLES
COULTER AC•T 5diff Hgb Lyse reagent is a clear,
aqueous solution containing potassium cyanide and
quaternary ammonium salts.
When the lytic reagent is added to a diluted whole-blood
sample, the surface-active properties of the quaternary
ammonium salts destroy the red cell membranes, thus
lysing the red blood cells (stromatolyzation) and releasing
the hemoglobin. The free hemoglobin chemically reacts with
the potassium cyanide to form a suitable chromagen
hemoglobin determination.
REACTIVE INGREDIENTS
Potassium Cyanide ................................................0.03%
Quaternary Ammonium Salts.................................2.67%
WARNINGS
 Product contains <2% Isopropyl Alcohol and
<2% Quaternary Ammonium Salts.
 Irritating to eyes.
 In case of contact with eyes, rinse immediately with
plenty of water and seek medical advice.
 Do not inhale and/or ingest.
 DO NOT REUSE CONTAINER.
STORAGE, STABILITY, AND DISPOSAL
 Store and use COULTER A
C
•T 5diff Hgb Lyse at
18-25°C.
 Do not use product past expiration date.
 Opened containers are stable for 3 months when used
at 18-25°C. Stability only applies to the reagent when
connected to the instrument with an approved reagent
pickup tube and cap.
 Dispose of waste product, unused product, and
contaminated packaging in compliance with federal,
state, and local regulations.
 DISCARD PRODUCT IF FROZEN.
PREPARATION
COULTER A
C
•T 5diff Hgb Lyse is ready to use. Replace
the reagent container as directed in your instrument
product manuals and/or online help.
IMPORTANT: DO NOT USE this product if it has been
partially or completely frozen. Dispose of product in
compliance with federal, state, and local regulations.
PRODUCT AVAILABILITY
COULTER A
C
•T 5diff Hgb Lyse - 1 x 400 mL
8547168
TRADEMARKS
A
C
•T, Beckman Coulter Logo, and COULTER are
trademarks of Beckman Coulter, Inc.
U.S. Patent Document Numbers 3,549,994 and 4,485,175
For additional information or if damaged product is
received, call Beckman Coulter Customer Service at
800-526-7694 (USA or Canada) or contact your local
Beckman Coulter Representative.
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821
www.beckmancoulter.com
Beckman Coulter Ireland Inc.
Mervue Business Park,
Mervue, Galway,
Ireland (353 91 774068)
Printed in USA
Made in USA
© 2009 Beckman Coulter, Inc.
All Rights Reserved.
COULTER
®
A
C
•T™ 5diff Hgb Lyse
8547168
PN 772262-AA