BEUDAMED
    FDA Enforcement Class II Terminated

    PREMIER EHEC and PREMIER EHEC Bulk.

    Recall: Z-1033-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1033-2017
    Event ID
    75651
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Meridian Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    November 8, 2016
    Classification Date
    January 17, 2017
    Termination Date
    August 16, 2017
    Address
    3471 River Hills Dr, Cincinnati, OH, 45244-3023, United States

    Description

    PREMIER EHEC and PREMIER EHEC Bulk.

    Reason

    Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.

    Code Info

    PREMIER EHEC Product Code 608096: Lot # 608096H219, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138 Exp Date 9/30/2017; Lot # 608096H222, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14 Exp Date 1/12/2018; Lot # 608096H224, Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.141 Exp Date 1/29/2018; Lot # 608096H225, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.142, Exp Date 2/5/2018 & Lot # 608096H226, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018. PREMIER EHEC Bulk Product Code 608096BU: Lot # 608096H220 Exp Date 9/7/2017, Detection Antibody Reagent, Lot # 8603.138, Exp Date 9/30/2017; Lot #, 608096H223, Exp Date 12/20/2017, Detection Antibody Reagent, Lot # 8603.14, Exp Date 1/12/2018 & Lot # 608096H227, Exp Date 3/6/2018, Detection Antibody Reagent, Lot # 8603.143, Exp Date 3/22/2018.

    Distribution

    Product was shipped to the following states: AL. AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY. Product was also sent to the following countries: CANADA, GERMANY, HONG KONG, ITALY, JAPAN & NEW ZEALAND.

    Quantity

    4,747 EHEC + 180 EHEC Bulk