BEUDAMED
    FDA Enforcement Class II Ongoing

    HemosIL ReadiPlasTin, Part No. 0020301400

    Recall: Z-1052-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1052-2022
    Event ID
    90012
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Instrumentation Laboratory
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 18, 2022
    Initiation Date
    April 8, 2022
    Classification Date
    May 10, 2022
    Address
    180 Hartwell Rd, N/A, Bedford, MA, 01730-2443, United States

    Description

    HemosIL ReadiPlasTin, Part No. 0020301400

    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 Info

    UDI 08426950632887 All in-date lots are affected by this recall.

    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)