BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT

    MDR report key: 24500984 · Received March 3, 2026

    Report

    Report Number
    3006948883-2026-00183
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 31, 2026
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    PSZ
    UDI-DI
    00382902560418
    PMA / PMN Number
    K120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA/510(K)#: K121797;K132256;K132693;K133138;K151301;K152874;K160164. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, ONE (1) FLU B POSITIVE PATIENT RESULT WAS OBTAINED FROM A VERITOR ANALYZER. IT WAS NOTED THE USER IMMEDIATELY RE-INSERTED THE SAME CARTRIDGE BACK INTO A VERITOR ANALYZER AND A FLU B NEGATIVE RESULT WAS OBTAINED. THE PATIENT SAMPLE WAS ALSO TESTED USING MOLECULAR PLATFORMS (LIAT ROCHE AND DIASORIAN), AND EACH PROVIDED A FLU B NEGATIVE RESULT. IT SHOULD BE NOTED THE ACTION OF REINSERTING A USED TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237469 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3275828 00382902560418

    Patients

    Seq Age Sex Outcome Treatment
    1