Recall Z-1052-2022 ยท GJS Test, Time, Prothrombin
Instrumentation Laboratory
HemosIL ReadiPlasTin, Part No. 0020301400
| Date | Apr 8, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On April 8, 2022, the firm notified customers via email and certified mail. Customers were informed that the firm will stop shipment of product on May 9, 2022. After receipt of the material, customers must complete the conversion to HemosIL RecombiPlasTin 2G, with support as needed from your local Werfen representative, within 90 days. Until a lot of HemosIL RecombiPlasTin 2G has been received and ready for use, customers should run quality control for HemosIL ReadiPlasTin with each new reagent vial (every lot) and at least every 8 hours to identify vials with performance issues. Any product |
| Quantity | 1,563 (US); 29,046 (OUS) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122584 | HEMOSIL READIPLAS TIN Instrumentation Laboratory CO, Mar 24, 2013 |