Product Safety Recalls

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Instrumentation Laboratory Recall 90012

Description: HemosIL ReadiPlasTin, Part No. 0020301400

Instrumentation Laboratory Recall 90012 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1052-2022
Event ID90012
Event DescriptionHemosIL ReadiPlasTin, Part No. 0020301400
Product TypeDevices
DistributionUS 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.
Quantity1,563 (US); 29,046 (OUS)
Recall ReasonVariable 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.
Device Classification20220518
Device Code InfoUDI 08426950632887 All in-date lots are affected by this recall.
Center Classification Date20220510
Recall Initiation Date20220408
Recalling FirmInstrumentation Laboratory
Initial Notification E-Mail
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