Device product
HemosIL ReadiPlasTin, Part No. 0020301400
Z-1052-2022
Product summary
- Event
- Event 90012
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,563 (US); 29,046 (OUS)
- Official record key
device-enforcement:Z-1052-2022
Official wording
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.
Code information: UDI 08426950632887 All in-date lots are affected by this recall.
Distribution pattern: 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.
Derived failure modes
-
Potency or specification failure
out of specification