Recall Z-1052-2022
Instrumentation Laboratory · initiated April 8, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HemosIL ReadiPlasTin, Part No. 0020301400
Codes / lots: UDI 08426950632887 All in-date lots are affected by this recall.
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 HemosIL RecombiPlasTin 2G.
FDA-determined cause: Under Investigation by firm
Action taken
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 with failed quality control or quality control results which trend high should be discarded. Once customers have completed the comversion to HemosIL RecombiPlasTin 2G, any remaining unused HemosIL ReadiPlasTin should be destroyed.
Details
- Recall number
- Z-1052-2022
- Initiated
- April 8, 2022
- Product code
- GJS – Test, Time, Prothrombin
- 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.
- Recalling firm
- Instrumentation Laboratory, Bedford, MA