BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24429733 · Received February 24, 2026

    Report

    Report Number
    3006948883-2026-00168
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 13, 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

    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 POSITIVE WHEN USING KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL#: 256041), BATCH NUMBER UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED FALSE POSITIVE RESULTS WITH 10 PATIENT SAMPLES; THEY REPORTED INITIALLY RECEIVING A POSITIVE RESULT, THEN A NEGATIVE RESULT WHEN REPEATING THE TEST WITH A NEW CARTRIDGE. THEY ALSO PERFORMED CONFIRMATORY MOLECULAR TESTING ON THE PATIENT SAMPLES. 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. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS FOR FALSE POSITIVE. 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, ONE (1) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER DID NOT SPECIFY IF THE ANALYTE IN QUESTION WAS FLU A OR FLU B AND NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER AFTER SEVERAL FOLLOW UP ATTEMPTS BY BD. THIS IS REPORT 10 OF 10.

    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) FALSE POSITIVE FLU RESULT WAS OBTAINED. UPON REPEAT TESTING USING A NEW TEST CARTRIDGE, A NEGATIVE FLU RESULT WAS OBTAINED. IN ADDITION, CONFIRMATORY MOLECULAR TESTING PROVIDED A NEGATIVE FLU RESULT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THE USER DID NOT SPECIFY IF THE ANALYTE IN QUESTION WAS FLU A OR FLU B AND NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE CUSTOMER AFTER SEVERAL FOLLOW UP ATTEMPTS BY BD. THIS IS REPORT 10 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475504 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