FDA Device recall Z-2323-2025
HemosIL LMW Heparin Controls
- FDA Device
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of HemosIL LMW Heparin Controls by Instrumentation Laboratory, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2323-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-03 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
Product
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Reason
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.
Identifiers
| code_info | Part Number: 0020300200; UDI-DI: 08426950472490; Lot Numbers: N0330228, N0632773, N0935135, N1036592, N0148986, N0441476, N0643673, N0845161, N1147397; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2323-2025%22
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