BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S HIV AG/AB COMBO REAGENT KIT

    MDR report key: 23449114 · Received November 3, 2025

    Report

    Report Number
    3002809144-2025-00343
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    September 17, 2025
    Report Date
    January 12, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117184
    PMA / PMN Number
    BL125679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. SECTION A1 PATIENT IDENTIFIER SIDS: (B)(6).

    Additional Manufacturer Narrative · 0

    UPON REVIEW, IDENTIFIED AN ERROR WITH SECTION D9 - DATE RETURNED TO MFR: CORRECTED TO UPDATE THIS FIELD FROM 11/11/2025 TO BLANK.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY S HIV AG/AB COMBO REAGENT LOT 74477BE00 IDENTIFIED NORMAL COMPLAINT ACTIVITY. FIELD DATA REVIEW SHOWED THAT THE REPEAT REACTIVE RATE OBSERVED FOR THE COMPLAINT LOT MEETS THE SPECIFICITY PERFORMANCE CLAIM OF THE PACKAGE INSERT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOTS. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. THE ALINITY S HIV AG/AB COMBO ASSAY 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. UPDATED SECTION B5.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35; BIORAD GENIUS WAS NEGATIVE, ON (B)(6) 2025, SID (B)(6) = 14.27 / 48.51 / 72.05 0.42 / S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = REPEAT REACTIVE; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = REPEAT REACTIVE; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = REPEAT REACTIVE; BIORAD GENIUS WAS NEGATIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, (B)(6) 2025 SID (B)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 45.50 / 45.75 / 49.93 / 0.11 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 5.72 / 1.75 / 6.15 / 0.07 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 5.14 / 6.16 / 8.69 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE , NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, (B)(6) 2025 SID (B)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE, SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE. SID (B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 45.50 / 45.75 / 49.93 / 0.11 S/CO; BIORAD GENIUS WAS NEGATIVE, SID (B)(6) = 5.72 / 1.75 / 6.15 / 0.07 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE, SID (B)(6) = 5.14 / 6.16 / 8.69 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REPEAT REACTIVE ALINITY S HIV AG/AB COMBO RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) = 5.12 / 1.83 / 5.79 / 0.35 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. (B)(6) 2025 SID (B)(6) = 14.27 / 48.51 / 72.05 / 0.42 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. SID (B)(6) = 259.76 / 243.47 / 231.68 / 230.5 S/CO; BIORAD GENIUS WAS NEGATIVE. SID (B)(6) = 240.04 / 227.62 / 236.70 / 281 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE. SID (B)(6) = 364.89 / 300.76 / 285.35 / 372.4 S/CO; BIORAD GENIUS WAS REACTIVE; NAT WAS NEGATIVE. SID (B)(6) = 7.23 / 5.09 / 5.09 S/CO; BIORAD GENIUS WAS NEGATIVE. SID (B)(6) = REPEAT REACTIVE, REPEAT RESULT = 35 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE. SID (B)(6) = 45.50 / 45.75 / 49.93 / 0.11 S/CO; BIORAD GENIUS WAS NEGATIVE. SID (B)(6) = 5.72 / 1.75 / 6.15 / 0.07 S/CO; BIORAD GENIUS AND NAT WERE NEGATIVE. SID (B)(6) = 5.14 / 6.16 / 8.69 / 0.09 S/CO; BIORAD GENIUS WAS NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277758 ALINITY S HIV AG/AB COMBO REAGENT KIT SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO QHM ABBOTT GMBH 74477BE00 00380740117184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY S SYSTEM, 06P16-01, (B)(6).| ALNTY S SYSTEM, 06P16-01, (B)(6).| ALNTY S SYSTEM, 06P16-01, (B)(6).| ALNTY S SYSTEM, 06P16-01, (B)(6).