HemosIL Liquid Anti-Xa- Automated chromogenic assay for the… — Class II medical device recall Z-0151-2022
Ongoing recall by Instrumentation Laboratory, reported 2021-10-27, distributed nationwide. Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability
| Recall number | Z-0151-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2021-08-25 |
| Classified | 2021-10-19 |
| Reported by FDA | 2021-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IR, IT, JP, KR, KW, LB, LK, LT, LU, MX, MY, NL, PL, PT, QA, RO, RS, RU, SA, SE, TH, TN, TR, TW, VN |
| Quantity | 40,224 |
| Reason classes | labeling, specification failure |
| Model numbers | 0020302601 |
Product
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
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-0151-2022. 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.