BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HAVAB IGG REAGENT KIT

    MDR report key: 23661546 · Received November 26, 2025

    Report

    Report Number
    3002809144-2025-00377
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 21, 2025
    Report Date
    February 26, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740131333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA FOUND IN SECTION D4 PRIMARY UDI NUMBER. A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I HAVAB IGG REAGENT LOT NUMBER 75248BE00 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSE REACTIVE 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. THE OVERALL PERFORMANCE OF ALINITY I HAVAB IGG REAGENTS IN THE FIELD WAS REVIEWED USING WORLDWIDE FIELD DATA FROM CUSTOMERS WORLDWIDE. THE NUMBER OF STANDARD DEVIATIONS TO CUTOFF AND PATIENT MEDIAN VALUES OF THE NEGATIVE POPULATION FOR THE COMPLAINT LOT(S) ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. REVIEW OF APPLICABLE FIELD DATA SHOWS THAT THE PERFORMANCE IS ACCEPTABLE. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I HAVAB IGG REAGENT LOT NUMBER 75248BE00.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P26 (ALINITY I HAVAB IGG) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6S93 (HAVAB IGG II) WITH 510K/PMA/BLA NUMBER K222850 AND LIST NUMBER 8P27 (ALINITY I HAVAB IGG) WITH 510K/PMA/BLA NUMBER K113704.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE INITIAL REACTIVE ALINITY I HAVAB IGG FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL HAVAB RESULT= 3.37 S/CO (REACTIVE); REPEAT RESULT (DIFFERENT LOT ON ANOTHER ANALYZER) = 0.38 S/CO (NONREACTIVE) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE INITIAL REACTIVE ALINITY I HAVAB IGG FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6), INITIAL HAVAB RESULT= 3.37 S/CO (REACTIVE); REPEAT RESULT (DIFFERENT LOT ON ANOTHER ANALYZER) = 0.38 S/CO (NONREACTIVE) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911884 ALINITY I HAVAB IGG REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) LOL ABBOTT GMBH 75248BE00 00380740131333

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)