HemosIL ReadiPlasTin — Class II medical device recall Z-1052-2022
Ongoing recall by Instrumentation Laboratory, reported 2022-05-18, distributed nationwide. Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the marke
| Recall number | Z-1052-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2022-04-08 |
| Classified | 2022-05-10 |
| Reported by FDA | 2022-05-18 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 08426950632887 |
| Model numbers | 0020301400 |
Product
HemosIL ReadiPlasTin, Part No. 0020301400
Reason for recall
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
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-1052-2022. 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.