BEUDAMED
    FDA Enforcement Class II Terminated

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    Recall: Z-0455-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0455-2022
    Event ID
    89130
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 12, 2022
    Initiation Date
    November 8, 2021
    Classification Date
    January 5, 2022
    Termination Date
    March 29, 2023
    Address
    19300 Germantown Rd, N/A, Germantown, MD, 20874-1415, United States

    Description

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    Reason

    The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.

    Code Info

    LOT 210209 UDI (01)14053228038846(17)211127(10)210209(24)691223 Serial Numbers: 412092551 412092559 412092552 412092560 412092553 412092561 412092554 412092563 412092555 412092564 412092556 412092565 412092557 412092566 412092558 412092567

    Distribution

    Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution.

    Quantity

    376 kits