BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1679-2022
    Event ID
    90789
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 14, 2022
    Initiation Date
    August 19, 2022
    Classification Date
    September 6, 2022
    Address
    1300 E Touhy Ave, N/A, Des Plaines, IL, 60018-3315, United States

    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.

    Code Info

    Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085.

    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