BEUDAMED
    FDA Enforcement Class III Ongoing

    In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;

    Recall: Z-1188-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1188-2024
    Event ID
    93902
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2024
    Initiation Date
    February 1, 2024
    Classification Date
    February 26, 2024
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315, United States

    Description

    In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;

    Reason

    Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

    Code Info

    (1) REF 01N15-010 - GTIN 00884999035362, Lot #381146, Exp. 2024-05-05; #381870, Exp. 2024-05-05; #382179 Exp. 2024-05-05; #387021, Exp. 2024-08-01; #528081, exp. 2023-11-16; (2) REF 01N34-020 - GTIN 00884999000766, Lot #522756, Exp. 2023-06-21.

    Distribution

    US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.

    Quantity

    16 kits