BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA COMBO 2 ASSAY

    MDR report key: 24257644 · Received February 4, 2026

    Report

    Report Number
    2024800-2026-00004
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    January 6, 2026
    Report Date
    February 4, 2026
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LSL
    UDI-DI
    15420045505711
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. WHILE THE CAUSE OF THE OBSERVED DISCREPANT RESULTS IS UNKNOWN, IT IS POSSIBLE THE STRING OF NINE DISCREPANT RESULTS WAS DUE TO KIT OR ENVIRONMENTAL CONTAMINATION IN THE LAB. HOLOGIC REVIEW DID NOT SHOW INDICATION OF INSTRUMENT CONTAMINATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE. H3 OTHER TEXT: OTHER.

    Description of Event or Problem · 0

    ON JANUARY 6, 2026, CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS ON NINE SAMPLES WHILE USING THE APTIMA COMBO 2 (AC2) ASSAY (ML 924882) ON THEIR PANTHER PLUS INSTRUMENT ((B)(6)). ON (B)(6) 2026, CUSTOMER INITIALLY TESTED THE NINE SAMPLES ON AC2 WORKLIST (WL) (B)(4) AND RECEIVED A CT POSITIVE/ GC POSITIVE RESULT ON SAMPLE ID (B)(6) AND CT NEGATIVE/GC NEGATIVE RESULTS ON THE OTHER EIGHT SID¿S; (B)(6). CUSTOMER SUSPECTED ENVIRONMENTAL CONTAMINATION AND RE-RAN THE SAMPLES IN QUESTION USING A NEWLY RECONSTITUTED ASSAY KIT. CUSTOMER PERFORMED A RETEST OF ALL NINE SAMPLES ON WORKLIST IDS (WL) (B)(4) AND (WL) (B)(4) AND RECEIVED A CT NEGATIVE/GC POSITIVE RESULT ON SAMPLE ID ((B)(6)) AND CT POSITIVE/GC NEGATIVE RESULTS ON SID; (B)(6). CUSTOMER REPORTED OUT THE RESULTS FROM THE INITIAL WL (B)(4). 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
    319766 APTIMA COMBO 2 ASSAY DNA-REAGENTS, NEISSERIA LSL HOLOGIC, INC. 924882 15420045505711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other