Instrumentation Laboratory Recall 90012
Description: HemosIL ReadiPlasTin, Part No. 0020301400
Instrumentation Laboratory Recall 90012 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1052-2022 |
| Event ID | 90012 |
| Event Description | HemosIL ReadiPlasTin, Part No. 0020301400 |
| Product Type | Devices |
| Distribution | US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV. |
| Quantity | 1,563 (US); 29,046 (OUS) |
| Recall 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. |
| Device Classification | 20220518 |
| Device Code Info | UDI 08426950632887 All in-date lots are affected by this recall. |
| Center Classification Date | 20220510 |
| Recall Initiation Date | 20220408 |
| Recalling Firm | Instrumentation Laboratory |
| Initial Notification | |
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