BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HAVAB IGG REAGENT KIT

    MDR report key: 24094620 · Received January 16, 2026

    Report

    Report Number
    3002809144-2026-00009
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    January 6, 2026
    Report Date
    March 31, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740131333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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.

    Additional Manufacturer Narrative · 0

    UPDATED D4: EXPIRATION DATE: TO 8/4/2026 FROM 4/20/2026; PRIMARY UDI NUMBER: TO (B)(4) FROM (B)(4). THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW OF ALINITY I HAVAB IGG REAGENT LOT NUMBER 79090BE00. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I HAVAB IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE NUMBER OF STANDARD DEVIATIONS TO CUTOFF AND PATIENT MEDIAN VALUES OF THE NEGATIVE POPULATION FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. THUS, THE REVIEW OF APPLICABLE FIELD DATA SUGGESTS THAT THE PERFORMANCE IS ACCEPTABLE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HAVAB IGG REAGENT LOT 79090BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I HAVAB IGG FOR ONE PATIENT. THE PATIENT¿S SAMPLE WAS REPEATED WITH NONREACTIVE RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL HAVAB IGG RESULT= 1.4 S/CO (REACTIVE); REPEAT RESULTS= 0.33 S/CO (NONREACTIVE), 0.32 (NONREACTIVE); SAMPLE WAS RECENTRIFUGED AND REPEAT RESULTS= 0.41 S/CO (NONREACTIVE), 0.64 S/CO (NONREACTIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154095 ALINITY I HAVAB IGG REAGENT KIT HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) LOL ABBOTT GMBH 79090BE00 00380740131333

    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).