BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CTGCTV2 (US)

    MDR report key: 25218568 · Received May 19, 2026

    Report

    Report Number
    3007420875-2026-00116
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 26, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    LSL
    UDI-DI
    00382904439040
    PMA / PMN Number
    K182692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. D.4. MEDICAL DEVICE LOT: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ CTGCTV2, A DISCREPANT TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. TV RESULT FROM THE SAME SWAB WAS NEGATIVE ON BD MAX¿ CTGCTV2, AND POSITIVE ON BD MAX¿ VAGINAL PANEL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523384 BD MAX¿ CTGCTV2 (US) MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT LSL GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) UNKNOWN 00382904439040

    Patients

    Seq Age Sex Outcome Treatment
    1