BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

    MDR report key: 24298570 · Received February 9, 2026

    Report

    Report Number
    3006948883-2026-00079
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 10, 2026
    Report Date
    March 16, 2026
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    PSZ
    UDI-DI
    00382902560456
    PMA / PMN Number
    K112277
    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)#: K132259;K132692;K151291;K152870;K160161;K180438;K223016;K232434. 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 RESULT (ERRONEOUS RESULT) WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 4289342. THE CUSTOMER REPORTED THAT THEY RECEIVED THREE ERRONEOUS RESULTS WITH THE SAME PATIENT. THEY WERE EXPECTING TO OBTAIN A POSITIVE RESULT, AND ARE REPORTING THAT THE LINE ON THE CARTRIDGE IS NOT IN THE CORRECT SPOT. 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 PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. NO SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THERE WERE 5 PHOTOS RECEIVED, SHOWING THE ANALYZER SERIAL NUMBER INFORMATION, THREE USED TEST CARTRIDGES, AND THE KIT BOX INFORMATION. THE PHOTO OF THE THREE TEST CARTRIDGES SHOWS 2 LINES: A CONTROL LINE AND A FAINT NEGATIVE CONTROL (NC) LINE. THE NC LINE, WHICH IS UNMARKED ON THE CARTRIDGE, FUNCTIONS TO BIND WITH INTERFERING ANTIBODIES THAT MAY BE PRESENT IN A SAMPLE AND WILL REDUCE THE CHANCES OF THESE INTERFERING BODIES TO BIND TO THE OTHER TEST LINES. SINCE THE POSITIVE CONTROL (C) LINE IS VISIBLE IN THE PHOTO RECEIVED, THE TESTS ARE VALID AND THE ASSAY IS THEREFORE FUNCTIONING AS EXPECTED. HOWEVER, THE ISSUE REPORTED CANNOT BE CONFIRMED THROUGH THIS IMAGE ALONE, WITHOUT ANALYZER DATA. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS WITH RESULT (ERRONEOUS RESULT). BASED ON THE TESTING PERFORMED, THE REPORTED ISSUE MAY BE A SAMPLE ISSUE AND IT IS RECOMMENDED THAT THE CUSTOMER USE A DIFFERENT TESTING METHODOLOGY IF THIS ISSUE REOCCURS. 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 CLIA-WAIVED KIT, THE CUSTOMER OBTAINED ONE (1) ERRONEOUS PATIENT RESULT ON A REPEATED (THIRD TIME) SPECIMEN. PER THE CUSTOMER, A POSITIVE RESULT WAS EXPECTED AS THE PATIENT WAS SYMPTOMATIC; HOWEVER, THE RESULT WAS CONSIDERED INCONCLUSIVE AS THE TESTING LINE WAS NOT IN THE CORRECT SPOT. THERE WAS NO REPORT OF PERFORMING CONFIRMATORY TESTING. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THE CUSTOMER 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT, THE CUSTOMER OBTAINED ONE (1) ERRONEOUS PATIENT RESULT ON A REPEATED (THIRD TIME) SPECIMEN. PER THE CUSTOMER, A POSITIVE RESULT WAS EXPECTED AS THE PATIENT WAS SYMPTOMATIC; HOWEVER, THE RESULT WAS CONSIDERED INCONCLUSIVE AS THE TESTING LINE WAS NOT IN THE CORRECT SPOT. THERE WAS NO REPORT OF PERFORMING CONFIRMATORY TESTING. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. IT SHOULD BE NOTED THE ACTION OF VISUAL INTERPRETATION OF A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THE CUSTOMER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360464 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 4289342 00382902560456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown