medical Class II Updated 2021-10-27

Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- Automated chromogenic assay for the

Recalled Product

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601


Hazard / Issue

Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All currently released lots and future lots
View official government recall

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