Official recall record
HemosIL LMW Heparin Controls; Part Number: 0020300200;
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-02-03
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Instrumentation Laboratory
What the authority reported
Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-05-21 · US FDA — Medical Devices
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GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 0007741501
All 18 official recall notices naming Instrumentation Laboratory on this site →
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