BEUDAMED
    FDA Enforcement Class II Terminated

    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

    Recall: Z-2137-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2137-2018
    Event ID
    80068
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thermo Fisher
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    May 4, 2018
    Classification Date
    June 8, 2018
    Termination Date
    December 19, 2018
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin).

    Reason

    Product may fail performance testing for S aureus ATCC 43300.

    Code Info

    Lot: 307200

    Distribution

    US Nationwide Distribution

    Quantity

    67 units