BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24283392 · Received February 6, 2026

    Report

    Report Number
    3006948883-2026-00074
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 12, 2026
    Report Date
    March 5, 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
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE NEGATIVE WHEN USING KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL#: 256041), BATCH NUMBER UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED FALSE FLU A NEGATIVE RESULTS. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE NOT PERFORMED AS THERE WAS NO BATCH NUMBER PROVIDED. NO PHOTOS OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE NEGATIVE WAS CONDUCTED; NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, AN UNSPECIFIED NUMBER OF FLU A FALSE NEGATIVE RESULTS WERE OBTAINED. IT WAS NOTED THE CUSTOMER WAS EXPECTING FLU A POSITIVE RESULTS. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT, AN UNSPECIFIED NUMBER OF FLU A FALSE NEGATIVE RESULTS WERE OBTAINED. IT WAS NOTED THE CUSTOMER WAS EXPECTING FLU A POSITIVE RESULTS. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE FOLLOW UP ATTEMPTS BY BD FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291878 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. UNKNOWN 00382902560418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown