BEUDAMED
    FDA Recall Open, Classified

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223

    Recall: Z-2245-2023 · Initiated May 19, 2023

    Recall

    Recall Number
    Z-2245-2023
    Event Number
    92609
    Firm
    Qiagen GmbH Qiagen Str. 1 Hilden Germany
    FEI Number
    3004013603
    Product Code
    QLT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 19, 2023
    Posted
    July 27, 2023

    Description

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223

    Reason

    Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

    Action

    Qiagen issued a customer letter (Urgent Medical Device Correction (REF 691223) or Urgent Field Safety notice (REF 691214) via e-mail on 5/19/23. Letter states reason for recall, health risk and action to take: Do not use the remaining stock of cartridges of LOTs 175010704 and 175011354. 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. " 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 02 June 2023. 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

    DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, SK, TH, TN, TW, UY, YT, ZA

    Quantity

    386 kits