BEUDAMED
    FDA Enforcement Class II Terminated

    MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.

    Recall: Z-1742-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1742-2019
    Event ID
    82761
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    June 8, 2018
    Classification Date
    June 6, 2019
    Termination Date
    October 30, 2020
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039, United States

    Description

    MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.

    Reason

    Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

    Code Info

    Lot numbers 64179161, exp. 6/8/2018; 64180987, exp. 6/15/2018; 64182474, exp. 6/23/2018; 64184888, exp. 6/30/2018; 64187551, exp. 7/6/2018; 64189117, exp. 7/13/2018; 64190797, exp. 7/22/2018; and 64192125, exp. 8/3/2018.

    Distribution

    US Nationwide Distribution to: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico.

    Quantity

    5,212 units