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Instrumentation Laboratory recalls HemosIL ReadiPlasTin, Part No. 0020301400
Recalled May 18, 2022 · FDA recall Z-1052-2022 · Instrumentation Laboratory
Hazard
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 Class II
Units
1,563 (US); 29,046 (OUS)
Sold at
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.
Description
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.
Product
HemosIL ReadiPlasTin, Part No. 0020301400
Manufacturer(s)
Instrumentation Laboratory
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →