BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 24277261 · Received February 6, 2026

    Report

    Report Number
    3005094123-2026-00061
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 19, 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 7P51 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21/31, AND 510K NUMBER K170317. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I TOTAL B-HCG REAGENT KIT, LIST NUMBER 07P51-74, AND MANUFACTURING SITE OF LONGFORD, IRELAND IN SECTION D OF THIS REPORT TO ALINITY I PROCESSING MODULE, LIST NUMBER 03R65-01, AND MANUFACTURING SITE IRVING, TX, USA OF NEW SUSPECT DEVICE. MDR NUMBER 3016438761-2026-00099 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED POSITIVE ALINITY I TOTAL BHCG RESULTS. SID (B)(653-YEAR-OLD, FEMALE) GENERATED ALINITY I TOTAL BHCG POSITIVE RESULT OF 116.78 MIU/ML, BUT COLLOIDAL GOLD METHOD NEGATIVE. THE SAMPLE WAS REPEATED WITH ALINITY I TOTAL BHCG NEGATIVE RESULT OF 0.8 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED POSITIVE ALINITY I TOTAL BHCG RESULTS. SID (B)(6) (53 YEAR OLD, FEMALE) GENERATED ALINITY I TOTAL BHCG POSITIVE RESULT OF 116.78 MIU/ML, BUT COLLOIDAL GOLD METHOD NEGATIVE. THE SAMPLE WAS REPEATED WITH ALINITY I TOTAL BHCG NEGATIVE RESULT OF 0.8 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344114 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 76209UD01 00380740163327

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).