BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 24210853 · Received January 29, 2026

    Report

    Report Number
    3002809144-2026-00021
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 17, 2026
    Report Date
    March 19, 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

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 77227BE01, HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE COMPLAINT LIST NUMBER, 07P87. A DEVICE HISTORY RECORD REVIEW DOES NOT IDENTIFY ANY RELATED NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. 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. 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 NOT AFFECTED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I ANTI-HBC II REAGENT LOT 77227BE01 WAS IDENTIFIED.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I ANTI-HBC RESULTS. PATIENT 1: INITIAL TEST: 0.66 S/CO NEGATIVE, HISTORICAL RESULT: 4.74 S/CO REACTIVE, CENTRIFUGATION RETEST: 4.50 S/CO REACTIVE. PATIENT 2: INITIAL TEST: 0.75 S/CO NEGATIVE, HISTORICAL RESULT: 3.71 S/CO REACTIVE, CENTRIFUGATION RETEST: 3.47 S/CO REACTIVE. REFERENCE RANGE: 0-1 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I ANTI-HBC RESULTS. PATIENT 1: INITIAL TEST: 0.66 S/CO NEGATIVE, HISTORICAL RESULT: 4.74 S/CO REACTIVE, CENTRIFUGATION RETEST: 4.50 S/CO REACTIVE. PATIENT 2: INITIAL TEST: 0.75 S/CO NEGATIVE, HISTORICAL RESULT: 3.71 S/CO REACTIVE, CENTRIFUGATION RETEST: 3.47 S/CO REACTIVE. REFERENCE RANGE: 0-1 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274520 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)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)