FDA Device recall Z-1052-2022
HemosIL ReadiPlasTin, Part No. 0020301400
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of HemosIL ReadiPlasTin, Part No. 0020301400 by Instrumentation Laboratory, citing 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) reage….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1052-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-08 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
Product
HemosIL ReadiPlasTin, Part No. 0020301400
Reason
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.
Identifiers
| code_info | UDI 08426950632887 All in-date lots are affected by this recall. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1052-2022%22
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