BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 23604332 · Received November 20, 2025

    Report

    Report Number
    3002809144-2025-00366
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 12, 2025
    Report Date
    February 5, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740162351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT ANTI-HCV REAGENT LOT NUMBER 79473BE01 TO ASSESS THE CUSTOMER¿S OBSERVATION OF FALSE NONREACTIVE 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. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE 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 ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (ZEPTOMETRIX HCV 9045). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO HISTORICAL ARCHITECT ANTI-HCV TEST RESULTS PROVIDED BY ZEPTOMETRIX. THE LOT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS ACCEPTABLE. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT ANTI-HCV REAGENT LOT NUMBER 79473BE01.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06C37 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01L79, ANTI-HCV, WITH PMA NUMBER P050042. 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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT ANTI-HCV FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL ANTI-HCV RESULT= 0.56 S/CO; ELISA METHOD RESULT= WEAK POSITIVE; TIME-RESOLVED METHOD RESULT= WEAK POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT ANTI-HCV FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL ANTI-HCV RESULT= 0.56 S/CO; ELISA METHOD RESULT= WEAK POSITIVE; TIME-RESOLVED METHOD RESULT= WEAK POSITIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661392 ARCHITECT ANTI-HCV ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 79473BE01 00380740162351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)