BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 23405685 · Received October 28, 2025

    Report

    Report Number
    3002809144-2025-00338
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    May 20, 2025
    Report Date
    November 3, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740169206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 08P06-23 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 08P05, WITH 510K/PMA/BLA NUMBER P050042. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A LABELING REVIEW, AND IN-HOUSE TESTING OF A RETAINED REAGENT KITS. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-HCV ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 69270BE00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 69270BE00, AND THE COMPLAINT ISSUE. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED. ALL CONTROLS MET SPECIFICATIONS, AND NO FALSE NONREACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE LOT PERFORMED AS EXPECTED. TESTING INCLUDED ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (ZEPTOMETRIX HCV 9045). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO THE TEST RESULTS PROVIDED BY ZEPTOMETRIX. REAGENT LOT 69270BE00 DETECTED THE SAME BLEEDS AS REACTIVE, WITH COMPARABLE S/CO VALUES FOR THE SEROCONVERSION PANEL. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I ANTI-HCV REAGENT, LOT NUMBER 69270BE00.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ALINITY I ANTI-HCV RESULTS ON A FEMALE PATIENT WHO WAS POSITIVE BY ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: ALINITY RESULTS: (B)(6) 2025 = 0.07 REAGENT LOT 69270BE00. POSITIVE RESULT FROM ANOTHER HOSPITAL METHOD UNKNOWN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ALINITY I ANTI-HCV RESULTS ON A FEMALE PATIENT WHO WAS POSITIVE BY ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: ALINITY RESULTS: (B)(6) 2025 = 0.07 REAGENT LOT 69270BE00. POSITIVE RESULT FROM ANOTHER HOSPITAL METHOD UNKNOWN. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028253 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 69270BE00 00380740169206

    Patients

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