Hemosll ReadiPlasTin — Class II medical device recall Z-0077-2019
Terminated recall by Instrumentation Laboratory Co., reported 2018-10-17, distributed nationwide. There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
| Recall number | Z-0077-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory Co., Bedford, MA, United States |
| Recall initiated | 2018-08-01 |
| Classified | 2018-10-05 |
| Reported by FDA | 2018-10-17 |
| Terminated | 2019-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 9,751 kits |
| Lot numbers | N0278177 |
| Model numbers | 0020301300 |
| Expiration dates | 2019-02-28 |
Product
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Reason for recall
There is a potential for 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-0077-2019. 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.