BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24056391 · Received January 13, 2026

    Report

    Report Number
    3006948883-2025-01003
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 15, 2025
    Report Date
    February 6, 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
    KS, 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 INCORRECT COMPONENTS WHEN USING KIT GRP A STREP 30 TEST VERITOR (MATERIAL#: 256040), BATCH NUMBER 5071160. THE CUSTOMER REPORTED THAT THEY RECEIVED A KIT THAT HAD THE INCORRECT QC SWABS. THE KIT HAD VERITOR COVID/FLU QC SWABS INSTEAD OF THE EXPECTED STREP A POSITIVE AND NEGATIVE QC SWABS. 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) AND RETAIN SAMPLE REVIEW 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. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS FOR INCORRECT COMPONENTS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER OPENING ONE (1) BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, THE CONTENTS INCLUDED VERITOR COVID/FLU QC SWABS INSTEAD OF THE EXPECTED GROUP A STREP POSITIVE AND NEGATIVE QC SWABS. THE CUSTOMER CONFIRMED THE KIT WAS SEALED UPON RECEIPT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER OPENING ONE (1) BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT, THE CONTENTS INCLUDED VERITOR COVID/FLU QC SWABS INSTEAD OF THE EXPECTED GROUP A STREP POSITIVE AND NEGATIVE QC SWABS. THE CUSTOMER CONFIRMED THE KIT WAS SEALED UPON RECEIPT. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116360 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. 5071160 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown