HemosIL ReadiPlasTin — Class II medical device recall Z-0276-2022
Ongoing recall by Instrumentation Laboratory, reported 2021-12-01, distributed nationwide. The firm has received customer reports of performance issues with the affected lot, including increased imprec
| Recall number | Z-0276-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2021-10-13 |
| Classified | 2021-11-24 |
| Reported by FDA | 2021-12-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CN, CR, IT, JP, KR |
| UPC / GTIN / UDI-DI | 08426950632887 |
| Lot numbers | N0705526, N0806224 |
| Model numbers | 0020301400 |
Product
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Reason for recall
The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.
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-0276-2022. 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.