Home / Recalls / Medical Devices
Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) a
Recalled October 27, 2021 · FDA recall Z-0149-2022 · Instrumentation Laboratory
Hazard
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days · FDA Class II
Units
64,114
Sold at
US Nationwide Foreign: Canada Armenia Austria Australia Belgium Brunei Brazil Belarus Switzerland China Colombia Czech Republic Germany Denmark Spain Finland France United Kingdom Gibraltar Greece Hong Kong Hungary Indonesia Ireland Israel India Iran Italy¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ Japan South Korea Kuwait Kazakhstan Lebanon Sri Lanka Lithuania Luxembourg Macau Mexico Malaysia Netherlands Poland Portugal Qatar Reunion Romania Serbia Russia Saudi Arabia Sweden Thailand Tunisia Turkey Taiwan Vietnam Zambia
Description
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
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, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro/8/9/10000) Part Number: 0020302600
Manufacturer(s)
Instrumentation Laboratory
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →