BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 24860717 · Received April 13, 2026

    Report

    Report Number
    2024800-2026-00019
    Event Type
    Injury
    Date Received
    April 13, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 13, 2026
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045512832
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC REVIEWED THE PANTHER LOGS AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES THAT AFFECTED RESULTS. THE ISSUE APPEARED TO BE SAMPLE RELATED, MOST LIKELY DUE TO LOW TARGET CONCENTRATION OR SAMPLE MISHANDLING. HOLOGIC HAS NOT LEARNED OF ANY PATIENT TREATMENT OR ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2026, CUSTOMER REPORTED RECEIVING DISCREPANT RESULTS WHILE USING THE APTIMA COMBO 2 (AC2) ASSAY (ML 924882) ON THEIR PANTHER PLUS INSTRUMENT (SN (B)(6). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED 15 SAMPLES ON AC2 WORKLIST (WL) (B)(6) AND RECEIVED A CT POSITIVE/GC NEGATIVE RESULT ON SEVEN SAMPLES, AND CT NEGATIVE/GC NEGATIVE RESULTS ON THE OTHER EIGHT SAMPLES. CUSTOMER WAS CONCERNED ABOUT A CLUSTER OF SIX CT POSITIVE/GC NEGATIVE SAMPLES AND RE-TESTED ALL 15 SAMPLES USING THE SAME AC2 ASSAY KIT. THE REPEAT(B)(6) CONTAINED DISCREPANT RESULTS ON FIVE SAMPLES: SID (B)(6) RESULTED CT NEGATIVE/GC NEGATIVE (ORIGINALLY CT POSITIVE/GC NEGATIVE) AND SID (B)(6) RESULTED CT POSITIVE/GC NEGATIVE (ORIGINALLY CT NEGATIVE/GC NEGATIVE). CUSTOMER REPORTED THE CT NEGATIVE/GC NEGATIVE RESULTS FROM THE REPEAT (B)(6) CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918307 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 924882 15420045512832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other