FDA-Device2022-05-18Class II
HemosIL ReadiPlasTin, Part No. 0020301400
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.
Sold states
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.
Affected count
1,563 (US); 29,046 (OUS)
Manufactured in
180 Hartwell Rd, N/A, Bedford, MA, United States
Products
HemosIL ReadiPlasTin, Part No. 0020301400
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1052-2022Don't want to check this manually?
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