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.
Other recalls by Instrumentation Laboratory
- HemoslL AcuStar HIT-lgG(PF-4)
FDA Device · Class I · 2026-10-21 · Instrumentation Laboratory - HemoslL AcuStar HIT-lgG(PF-4)
FDA Device · Class I · 2026-10-21 · Instrumentation Laboratory - GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory - GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The G…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory
All Instrumentation Laboratory recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1052-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.