BEUDAMED
    FDA Recall Open, Classified

    Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.

    Recall: Z-1679-2022 · Initiated August 19, 2022

    Recall

    Recall Number
    Z-1679-2022
    Event Number
    90789
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    QJR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 19, 2022
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.

    Reason

    Reports received of an increase of message code 9186 (internal control failed) when using the kit.

    Action

    The firm issued recall letters dated 8/19/2022 via FedEx priority overnight express on 8/19/2022. The letters provided the background, potential impact, and necessary actions. The necessary actions included contacting Abbott Customer Support for replacement of any unused kits in the consignee's inventory of the affected lot number and discard any inventory in their possession. If replacement inventory is not available, the consignee was told they may continue to use the affected product until replacement material is obtained. They are to ensure that valid Control values are obtained for all control levels prior to reporting results as specified in the associated package Insert. A Customer Reply Form was enclosed for completion and return. If the consignee has forwarded any kits of the affected lot to other laboratories, they are instructed to inform them of the recall, provide them a copy of the letter, and have them take the necessary actions listed. The letter also instructs the consignee to inform their laboratory personnel of the issue and retain a copy of the communication for further reference.

    Distribution

    Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Chile and Taiwan.

    Quantity

    579 kits