BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT

    MDR report key: 23881223 · Received December 23, 2025

    Report

    Report Number
    3006948883-2025-00959
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 8, 2025
    Report Date
    March 9, 2026
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GTY
    UDI-DI
    00382902560401
    PMA / PMN Number
    K122718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 GRP A STREP 30 TEST VERITOR (MATERIAL#: 256040), BATCH NUMBER 5142426. THE CUSTOMER REPORTED THAT THEY RECEIVED FALSE POSITIVE RESULTS WITH 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 PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. 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 POSITIVE 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 GROUP A STREP CLIA-WAIVED KIT, AN UNSPECIFIED NUMBER OF FALSE POSITIVE GROUP A STREP PATIENT RESULTS WERE OBTAINED. UPON PERFORMING THROAT CULTURE TESTING, NEGATIVE GROUP A STREP RESULTS WERE OBTAINED. THE CUSTOMER ALSO CONFIRMED THAT TESTING WITH A NEW KIT LOT PROVIDED NEGATIVE GROUP A STREP RESULTS AS EXPECTED. 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 GROUP A STREP CLIA-WAIVED KIT, AN UNSPECIFIED NUMBER OF FALSE POSITIVE GROUP A STREP PATIENT RESULTS WERE OBTAINED. UPON PERFORMING THROAT CULTURE TESTING, NEGATIVE GROUP A STREP RESULTS WERE OBTAINED. THE CUSTOMER ALSO CONFIRMED THAT TESTING WITH A NEW KIT LOT PROVIDED NEGATIVE GROUP A STREP RESULTS AS EXPECTED. 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
    166567 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 5142426 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown