BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 24732092 · Received March 30, 2026

    Report

    Report Number
    3005094123-2026-00149
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740163327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 07P51-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 7P51-21 / 31, WITH 510K NUMBER: K170317. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I TOTAL B-HCG ON A 28-YEAR-OLD FEMALE. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING RESULTS WERE PROVIDED: SID: (B)(6); INITIAL RESULT= <2.3 MIU/ML, REPEAT RESULT (AUTO DILUTION) = <7000 MIU/ML, REPEAT RESULTS = <2.3 MIU/ML (MANUAL DILUTION 2X & 5X) COLLOIDAL GOLD RESULT= POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126381 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 81525UD01 00380740163327

    Patients

    Seq Age Sex Outcome Treatment
    1