BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CTGCTV2

    MDR report key: 24956303 · Received April 22, 2026

    Report

    Report Number
    3007420875-2026-00095
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 26, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    LSL
    UDI-DI
    00382904439064
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY. 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, AN UNSPECIFIED NUMBER OF TRICHOMONAS VAGINALIS (TV) FALSE POSITIVE PATIENT RESULTS WITH UNUSUAL PCR CURVE WERE OBTAINED. POSITIVE SAMPLES WERE REPEATED ON MAX AND WERE TV NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS IS REPORT 3 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189568 BD MAX¿ CTGCTV2 MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT LSL GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5262904 00382904439064

    Patients

    Seq Age Sex Outcome Treatment
    1