The product is used for the evaluation of the intrinsic coagulation… — Class II medical device recall Z-1095-2026
Ongoing recall by Instrumentation Laboratory, reported 2026-01-21, distributed nationwide. Potential for microbial contamination.
| Recall number | Z-1095-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2025-12-11 |
| Classified | 2026-01-15 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, CN, HK, IL, IT, KR, LT, LU, MY, NL, PH, QA, RO, TR |
| Quantity | 7,720 units |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 08426950078920 |
| Lot numbers | N1136730 |
| Model numbers | 0020006800 |
| Expiration dates | 2025-12-31 |
Product
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Reason for recall
Potential for microbial contamination.
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-1095-2026. 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.