HemosIL LMW Heparin Controls — Class II medical device recall Z-2323-2025
Ongoing recall by Instrumentation Laboratory, reported 2025-08-20, distributed nationwide. Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recov
| Recall number | Z-2323-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2025-02-03 |
| Classified | 2025-08-13 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, ES, FI, GB, GR, GT, HK, HU, IE, IL, IN, IT, JP, KR, KW, LB, LT, MX, MY, PA, PE, PL, PT, PY, QA, RO, RS, RU, SA, SE, TH, TN, TR, UY, VN, ZA |
| Quantity | 41,824 units |
| UPC / GTIN / UDI-DI | 08426950472490 |
| Lot numbers | N0148986, N0330228, N0441476, N0632773, N0643673, N0845161, N0935135, N1036592, N1147397 |
| Model numbers | 0020300200 |
Product
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2323-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.