BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 23631405 · Received November 24, 2025

    Report

    Report Number
    3005094123-2025-00594
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 4, 2025
    Report Date
    January 23, 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

    THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY REVIEW AND ACCURACY TESTING OF ALINITY I TOTAL B-HCG REAGENT LOT 76209UD00. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I TOTAL B-HCG ASSAY DID IDENTIFY AN SLIGHT INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT LOT 76209UD00, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 07P51. IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH RETAINED COMPLAINT LOT NUMBER 76209UD00. THE TESTING MET VALIDITY AND ACCEPTANCE CRITERIA. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I TOTAL B-HCG REAGENT, LOT NUMBER 76209UD00.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I B-HCG RESULTS WHICH QUESTIONED BY THE PHYSICIAN FOR A PATIENT. THE RESULTS PROVIDED WERE: INITIAL= 249.40 MIU/ML (> 25.0 IU/L =POSITIVE) /REPEATED =< 0.1 MIU/ML (< OR =5.0 MIU/ML=NEGATIVE) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I B-HCG RESULTS WHICH QUESTIONED BY THE PHYSICIAN FOR A PATIENT. THE RESULTS PROVIDED WERE: INITIAL= 249.40 MIU/ML (> 25.0 IU/L =POSITIVE) /REPEATED =< 0.1 MIU/ML (< OR =5.0 MIU/ML=NEGATIVE) THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628773 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 NA Unknown ALNTY I PROCESSING MODU, 03R65-01,(B)(6)