BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 23571908 · Received November 17, 2025

    Report

    Report Number
    3002809144-2025-00364
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    November 9, 2025
    Report Date
    February 6, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740162580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P84, WITH 510K/PMA/BLA NUMBER P080023.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I ANTI-HBC II REAGENT LOT NUMBER 77227BE01 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSE NONREACTIVE RESULTS. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE ALINITY I ANTI-HBC II COMPLAINT LOT WAS PERFORMED. ALL SPECIFICATIONS WERE MET AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING A COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (BIOMEX SEROCONVERSION PANEL SCP-HBV-001). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT ANTI-HBC II TEST RESULTS PROVIDED BY BIOMEX. THE LOT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANEL. BASED ON THIS DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS ACCEPTABLE. NOTE: ALINITY I ANTI-HBC II AND ARCHITECT ANTI-HBC II UTILIZE THE SAME REAGENTS AND SAMPLE/REAGENT RATIOS. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I ANTI-HBC II REAGENT LOT NUMBER 77227BE01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I ANTI-HBC II FOR ONE PATIENT WITH CHRONIC HEPATITIS. THE FOLLOWING RESULTS WERE PROVIDED: CUSTOMER REFERENCE RANGE <1 S/CO. INITIAL ANTI-HBS RESULT= 0.773 S/CO; REPEAT RESULTS= 7.363 S/CO, 6.363 S/CO; REPEAT RESULT ON ROCHE ANALYZER= 0.01 COI (POSITIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I ANTI-HBC II FOR ONE PATIENT WITH CHRONIC HEPATITIS. THE FOLLOWING RESULTS WERE PROVIDED: CUSTOMER REFERENCE RANGE <1 S/CO. INITIAL ANTI-HBS RESULT= 0.773 S/CO; REPEAT RESULTS= 7.363 S/CO, 6.363 S/CO; REPEAT RESULT ON ROCHE ANALYZER= 0.01 COI (POSITIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2874367 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 77227BE01 00380740162580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6).