9-2 Sysmex XP-300
Quality Control
Revised July 2012
Warning and precautions
Do not inject or ingest.
The human blood used for the production of EIGHTCHECK-3WP-
N, EIGHTCHECK-3WP-L and EIGHTCHECK-3WP-H has been
tested with licensed reagents (Food and Drugs Administration’s
Bureau of Biologic, USA) and has been found non-reactive for
Hepatitis B Surface Antigen, Hepatitis C Virus (HCV) and HIV
(HIV1+HIV2) Antibody. However, none of the test methods known
today can guarantee that products based on human blood are not
infectious. In keeping with good laboratory practice, this product
should be considered potentially capable of transmitting infectious
disease.
Composition
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H contain stabilized human erythrocytes,
fixed human white blood cells and a platelet component in a medium
containing preservatives.
Storage and shelf life after first opening
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H are to be stored at 2-8ºC before and after
opening.
When handled in this manner, the unopened product is guaranteed
stable until the expiration date stated on the package.
After opening, the product is stable for 7 days if returned to the
refrigerator promptly after use.
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H have been tested and found to provide
stable parameter values after at least 12 hours at room temperature
(25ºC).
Additional special equipment
EIGHTCHECK-3WP-N, EIGHTCHECK-3WP-L and
EIGHTCHECK-3WP-H are intended to be used with SYSMEX
reagents and analyzers only.
Refer to the instrument manual for further information.
If other control materials are used the product performance
of Sysmex instruments cannot be guaranteed.
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