HemosIL ReadiPlasTin, Part No. 0020301400
Check against the official notice below — it lists the full affected range.
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin (Part No. 0020301400), a prothrombin time (PT) reagent used in blood testing, due to variable and out of specification quality control results. All in-date lots of the product, identified by UDI 08426950632887, are affected. The product was distributed nationwide across 21 U.S. states, with 1,563 units distributed in the US and 29,046 units distributed outside the US.
Instrumentation Laboratory will remove all affected lots from the market and will convert customers to an alternative PT reagent called HemosIL RecombiPlasTin 2G. The source does not specify what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 1,563 (US); 29,046 (OUS) Lot/code info: UDI 08426950632887 All in-date lots are affected by this recall.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.