Home / Recalls / Instrumentation Laboratory / Z-0150-2022

Z-0150-2022 Class II Ongoing

Recalled by Instrumentation Laboratory — Bedford, MA

Recall Details

Product Type
Devices
Report Date
October 27, 2021
Initiation Date
August 25, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25,738 US

Product Description

HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602

Reason for Recall

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

Distribution Pattern

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

Code Information

All currently released lots and future lots

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  • Z-1525-2026 Class II — GEM Premier 5000 PAK; Part No. 00055360008. (January 20, 2026)
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  • Z-1533-2026 Class II — GEM Premier 5000; Part No. 00055415005. (January 20, 2026)
  • Z-1524-2026 Class II — GEM Premier 5000 PAK, Part No. 00055360004. (January 20, 2026)
  • Z-1541-2026 Class II — GEM Premier 5000; Part No. 00055445004. (January 20, 2026)
  • Z-1540-2026 Class II — GEM Premier 5000; Part No. 00055430011. (January 20, 2026)