BEUDAMED
    FDA Enforcement Class II Ongoing

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

    Recall: Z-2246-2023 · Reported August 2, 2023

    Enforcement

    Recall Number
    Z-2246-2023
    Event ID
    92609
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Qiagen GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 2, 2023
    Initiation Date
    May 19, 2023
    Classification Date
    July 27, 2023
    Address
    Qiagen Str. 1, N/A, Hilden, N/A, N/A, Germany

    Description

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214

    Reason

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

    Code Info

    LOT Numbers: LOTs 172043034, 172043348, 172043349, 172043369, 172044712, 172048091, 172048388, 172048394, 172048396, 175010065, 175010066, 175010086, 175010669, 172046775, 172048381 Exp. Date: 2023-10-06 and 2023-10-17

    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

    4155 kits