BEUDAMED
    FDA Recall Open, Classified

    In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;

    Recall: Z-1189-2024 · Initiated February 1, 2024

    Recall

    Recall Number
    Z-1189-2024
    Event Number
    93902
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    MVU
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 1, 2024
    Posted
    February 26, 2024
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;

    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.

    Action

    The recalling firm issued letters dated and issued on 2/1/2024 via FedEx priority overnight express mail. The letter explained the background, potential impact, and necessary actions to be taken and contained an appendix listing Impacted Abbott Products and an appendix listing CE products and similar US products. The actions to be taken were to destroy all remaining inventory of the impacted products and contact their local Abbott representative for replacements. If the product has been forwarded to other laboratories, the consignee is requested to inform them of the recall and have them take the necessary actions. The letter states that laboratories should follow internal procedures in regard to a lookback of results and a lookback should be considered if results have been released that are tied to performance claims. A Customer Reply Form was enclosed to acknowledge receipt of the letter. The consignee was to record the amount of affected product that was destroyed.

    Distribution

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

    Quantity

    7 kits