Drug recall
HemosIL ReadiPlasTin, Part No. 0020301400
FDA recall event 90012 · Class II · Instrumentation Laboratory
Key facts
| Event ID | 90012 |
|---|---|
| Recall numbers | Z-1052-2022 |
| Recalling firm | Instrumentation Laboratory |
| Product type | Devices |
| Products | HemosIL ReadiPlasTin, Part No. 0020301400 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 8, 2022 |
| Report date | May 18, 2022 |
| City | Bedford |
| State | MA |
| Country | United States |
| FEI number | 1217183 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: