SYSMEX XE-5000, Инструкция по эксплуатации, Страница: 49 / 262

CHAPTER 4 Reagents
Sysmex XE-5000 Instructions for Use 4-7
Revised Apr
il
2
007 EU
4.13 Control blood ( e -CHECK(XE))
Intended Use
e -CHECK(XE) is a hematology control material primarily for
intralaboratory quality control of automated, semiautomated
and manual procedures that measure components of blood.
Additionally,
e -CHECK(XE) can be used in external quality
assessment.
Warnings and Precautions
Storage and Shelf Life after first Opening
Store control material as per product insert at +2 to +8°C.
If unopened,
e -CHECK(XE) may be used up to the expiration
date shown on the container. Once opened, it should be used
within 14 days.
4.14 Labeling
Important information about the handling of reagents and
quality control material is noted on the package insert and
containers. Please read the labels and package insert prior to
use.
Risk of infection
When using control blood, use personal protective
equipment. After completion of the analysis, be sure to
wash your hands with disinfectant.
Warning!
Potentially Infectious Material-All human source
material used to manufacture this product was non-
reactive for antigens to Hepatitis B9(HbsAg), negative
by tests for antibodies to HIV(HIV-1/HIV-2) and
Hepatitis C9(HCV), non-reactive for HIR-1 RNA and
HCV RNA by licensed NAT, and non-reactive to
Serological Test for Syphilis(STS) using techniques
specified by the U.S Food and Drug Administration.
Because no known test method can assure complete
absence of human pathogens, this product should be
handled with appropriate precautions.