BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 25046037 · Received April 30, 2026

    Report

    Report Number
    3002809144-2026-00111
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 30, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740162665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 08P06-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P05, WITH 510K/PMA/BLA NUMBER P050042. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NONREACTIVE ALINITY I ANTI-HCV RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: SAMPLE 1: SID (B)(6), (31-YEAR-OLD, MALE): ALINITY I ANTI-HCV = 0.16 / 0.17 S/CO (NONREACTIVE) WANTAI PLATFORM = 2.36 AND 2.71 S/CO AFTER HIGH-SPEED CENTRIFUGATION (POSITIVE) ROCHE CHEMILUMINESCENCE PLATFORM = 5.17 COI (POSITIVE) . ADDITIONAL TESTING PROVIDED: HCV AG RESULT = 0.00 FMOL/L RESULTS OF THE HEPATITIS B FIVE-ASSAY PANEL RESULTS: ANTI-HBS, ANTI-HBE, AND ANTI-HBC GENERATED POSITIVE RESULTS; HBSAG AND HBEAG GENERATED NEGATIVE RESULTS. THE PATIENT HAS A HISTORY OF POOR APPETITE, HELICOBACTER PYLORI INFECTION, AND ABNORMAL LIVER FUNCTION TESTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262759 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 81196BE01 00380740162665

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)