BEUDAMED
    FDA Recall Open, Classified

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

    Recall: Z-2215-2023 · Initiated May 9, 2023

    Recall

    Recall Number
    Z-2215-2023
    Event Number
    92540
    Firm
    Qiagen GmbH Qiagen Str. 1 Hilden Germany
    FEI Number
    3004013603
    Product Code
    QJR
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    May 9, 2023
    Posted
    July 21, 2023

    Description

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

    Reason

    If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported

    Action

    Qiagen issued Urgent Medical Device Correction Correction letter via e-mail on 5/9/23. For bounced e-mails, alternative suitable contacts will be identified. Letter states reason for recall, health risk and action to take: Please check if you have remaining stock of LOT 175010712. Do not use the remaining stock of cartridges of LOT 175010712. 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. 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 19. 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

    AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA

    Quantity

    368 kits