BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S ANTI-HCV REAGENT KIT

    MDR report key: 23449241 · Received November 3, 2025

    Report

    Report Number
    3002809144-2025-00346
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 7, 2025
    Report Date
    November 10, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117191
    PMA / PMN Number
    BL125677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION FOR POTENTIAL FALSE REACTIVE RESULTS FOR ALINITY S ANTI-HCV REAGENT INCLUDED A REVIEW OF TRENDING DATA, LABELING, DEVICE HISTORY RECORD, AND A COMPLAINT SEARCH. THE COMPLAINT DATA FOR THE PRODUCT IDENTIFIED NORMAL COMPLAINT ACTIVITY FOR THE COMPLAINT ISSUE AND NO TRENDS WERE IDENTIFIED. LABELING REVIEW CONCLUDED THE LABELING ADEQUATELY ADDRESSES THE ISSUE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS. 50,545 DECEASED DONORS WERE TESTED WITH ALINITY S ANTI-HCV, AND THE REACTIVE RATE, AS WELL AS THE SPECIFICITY, ASSUMING ZERO PREVALENCE, IS WITHIN SPECIFICATIONS FOR THE ASSAY. KIT TESTING OR REVIEW OF FIELD DATA WAS NOT PERFORMED, AS THE LOT NUMBERS IN USE WERE NOT AVAILABLE AND THE REVIEW OF THE PROVIDED DATA DOCUMENTED IN THE ARTICLE SHOWED PERFORMANCE WITHIN SPECIFICATIONS FOR THE ASSAY. BASED ON THE RESULTS OF THIS INVESTIGATION, THE ALINITY S ANTI-HCV REAGENT, IS PERFORMING AS EXPECTED AND NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    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

    AN ARTICLE BY SARA O. DIONNE, HILLARY C. S. R. AKANA, MICHAEL REAL, KIMBERLY A. ELLIOTT, BRENDEN R. O¿NEALE ¿INCREASED SEROLOGIC REACTIVITY WITH AUTOMATED CMIA TESTING AND ITS IMPLICATIONS FOR DECEASED DONOR ELIGIBILITY DETERMINATION IN THE UNITED STATES¿, CELL TISSUE BANK (2025) 26:40 MENTIONS REPEAT REACTIVE RESULTS FOR SAMPLES WITH ALINITY S HIV AG/AB COMBO, ALINITY S HTLV I/II, ALINITY S ANTI-HCV, ALINITY S HBSAG, AND ALINITY S ANTI-HBC. IT ALSO STATES THAT SOME SAMPLES WERE DISCREPANT TO NAT. THESE RESULTS COULD LEAD TO REJECTION OF DONATED TISSUE SAMPLES. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    AN ARTICLE BY SARA O. DIONNE, HILLARY C. S. R. AKANA, MICHAEL REAL, KIMBERLY A. ELLIOTT, BRENDEN R. O¿NEALE ¿INCREASED SEROLOGIC REACTIVITY WITH AUTOMATED CMIA TESTING AND ITS IMPLICATIONS FOR DECEASED DONOR ELIGIBILITY DETERMINATION IN THE UNITED STATES¿, CELL TISSUE BANK (2025) 26:40 MENTIONS REPEAT REACTIVE RESULTS FOR SAMPLES WITH ALINITY S HIV AG/AB COMBO, ALINITY S HTLV I/II, ALINITY S ANTI-HCV, ALINITY S HBSAG, AND ALINITY S ANTI-HBC. IT ALSO STATES THAT SOME SAMPLES WERE DISCREPANT TO NAT. THESE RESULTS COULD LEAD TO REJECTION OF DONATED TISSUE SAMPLES. NO IMPACT TO DONOR MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758506 ALINITY S ANTI-HCV REAGENT KIT SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO QHM ABBOTT GMBH 00380740117191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY S SYSTEM, 06P16-01, SN# UNKNOWN| ALNTY S SYSTEM, 06P16-01, SN# UNKNOWN