BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CTGCTV2

    MDR report key: 24716087 · Received March 30, 2026

    Report

    Report Number
    3007420875-2026-00068
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 25, 2026
    Report Date
    April 9, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    LSL
    UDI-DI
    00382904439798
    PMA / PMN Number
    K210585
    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

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY, QEP 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 CHLAMYDIA TRACHOMATIS (CT) PATIENT RESULT WAS OBTAINED. SAMPLE INITIALLY TESTED CT POSITIVE. SAMPLE WAS THEN REPEATED AND WAS CT NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776612 BD MAX¿ CTGCTV2 MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT LSL GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5237366 00382904439798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown