BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1683-2023 · Initiated April 28, 2023

    Recall

    Recall Number
    Z-1683-2023
    Event Number
    92298
    Firm
    Qiagen Sciences LLC
    FEI Number
    3003572099
    Product Code
    QLT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 28, 2023
    Posted
    June 2, 2023
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415

    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.

    Action

    An Urgent Medical Device Correction notification letter dated April 2023 was sent to customers. Actions to be taken by customer/user Please check if you have remaining stock of LOT 175011350. Please DO NOT use it. Dispose of it immediately in accordance to your national and local safety and environmental regulations. Please contact QIAGEN Technical Services for a free-of-charge replacement. If you already used cartridges from this LOT, please identify the results obtained with cartridges from the affected SN. For results obtained with an affected SN, review the results as follows: o Review all results of the respective targets mentioned in this notice to exclude erroneous diagnosis and treatment, except in those cases where alternative confirmation was obtained. o Review any result for which tests were performed on clinical and/or epidemiological suspicion of the respective targets. Review this notice with your laboratory/medical director. IMPORTANT: Forward this information to all individuals and departments within your organization using the above listed kits. If you are not the end user, please forward this notice to the product end user. Complete the Acknowledgement of Receipt Form attached to this letter by 14 May 2023. Actions taken by QIAGEN QIAGEN was able to identify the root cause of the issue and has implemented immediate actions to ensure that the currently produced cartridges will not cause this issue moving forward. If you have any questions or concerns, please contact your local QIAGEN Technical Services Department through any of the following: Telephone: 800 362 7737 Email: [email protected]

    Distribution

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

    Quantity

    347 kits