BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 23821837 · Received December 16, 2025

    Report

    Report Number
    3008344661-2025-00184
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 27, 2025
    Report Date
    February 20, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740138059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND IN HOUSE TESTING OF ARCHITECT ANTI-HBS REAGENT, LOT 75318FZ00. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT ANTI-HBS ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR ANTI-HBS REAGENT LOT 75318FZ00. IN-HOUSE SPECIFICITY TESTING OF A RETAINED KIT OF LOT 75318FZ00 WAS COMPLETED. ALL SPECIFICATIONS WERE MET, INDICATING THE LOT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND THE COMPLAINT ISSUE. THE PRODUCT LABELLING PROVIDES APPROPRIATE INFORMATION RELATED TO THE CUSTOMER ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT ANTI-HBS REAGENT LOT 75318FZ00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7C18 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L82, WITH 510K/PMA/BLA NUMBER P050051. 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 REACTIVE ARCHITECT ANTI-HBS FOR MULTIPLE PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. BEGINNING IN (B)(6), THE CUSTOMER NOTED THAT PATIENT INITIAL RESULTS WERE POSITIVE, BUT WHEN REPEATED WOULD BE NEGATIVE. THERE WAS NO SPECIFIC PATIENT RESULTS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT ANTI-HBS FOR MULTIPLE PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. BEGINNING IN AUGUST, THE CUSTOMER NOTED THAT PATIENT INITIAL RESULTS WERE POSITIVE, BUT WHEN REPEATED WOULD BE NEGATIVE. THERE WAS NO SPECIFIC PATIENT RESULTS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1876321 ARCHITECT ANTI-HBS TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 75318FZ00 00380740138059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2K PROC MOD, 03M74-01, (B)(6).