Home / Recalls / Instrumentation Laboratory / Z-0151-2022

Z-0151-2022 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
40,224

Product Description

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

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

Other recalls by Instrumentation Laboratory

  • Z-1526-2026 Class II — GEM Premier 5000 PAK; Part No. 00055360010. (January 20, 2026)
  • Z-1531-2026 Class II — GEM Premier 5000 PAK; Part No. 00055407511. (January 20, 2026)
  • Z-1535-2026 Class II — GEM Premier 5000; Part No. 00055415010. (January 20, 2026)
  • Z-1529-2026 Class II — GEM Premier 5000 PAK; Part No. 00055407508. (January 20, 2026)
  • Z-1525-2026 Class II — GEM Premier 5000 PAK; Part No. 00055360008. (January 20, 2026)
  • Z-1542-2026 Class II — GEM Premier 5000; Part No. 00055445008. (January 20, 2026)
  • 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)