Hemosll ReadiPlasTin — Class II medical device recall Z-0895-2018
Terminated recall by Instrumentation Laboratory Co., reported 2018-03-14, distributed nationwide. Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N11
| Recall number | Z-0895-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory Co., Bedford, MA, United States |
| Recall initiated | 2017-08-02 |
| Classified | 2018-03-03 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2019-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 14,894 kits |
| Lot numbers | N0177760, N0278177, N0278358, N0478057, N0479504, N1166235 |
| Model numbers | 0020301400 |
Product
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Reason for recall
Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
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-0895-2018. 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.