BEUDAMED
    FDA Enforcement Class II Ongoing

    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

    Recall: Z-1683-2023 · Reported June 14, 2023

    Enforcement

    Recall Number
    Z-1683-2023
    Event ID
    92298
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2023
    Initiation Date
    April 28, 2023
    Classification Date
    June 2, 2023
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415, United States

    Description

    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

    Reason

    Faulty cartridges in the lot could result in false test results.

    Code Info

    GTIN 14053228038846; Lot 175011350; Serial Numbers within the range of 330568064 to SN 330568597 AND 330569655, 330569651, 330569650, 330569646, 330569645, 330569644, 330569643, 330569641.

    Distribution

    US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN.

    Quantity

    347 kits