BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP

    MDR report key: 23309286 · Received October 16, 2025

    Report

    Report Number
    3002809144-2025-00324
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    November 1, 2019
    Report Date
    November 26, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740155438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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 08D06-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-31 / 41, WITH 510K NUMBER K153730. 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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT SYPHILIS TP ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW DOES NOT IDENTIFY ANY RELATED NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SYPHILIS TP ASSAY WAS IDENTIFIED.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE BY WAJNAT A. TOUNSI, ET.AL., ¿THE ¿GREY ZONE¿ IN BLOOD DONOR SCREENING: A RETROSPECTIVE STUDY AND PROPOSAL FOR DONOR RE-ENTRY¿, DIAGNOSTICS 2025, 15, 2261. MDPI AG, DOCUMENTED FALSE NONREACTIVE ANTI-HBC, HBSAG, ANTI-HCV, HTLV, AND SYPHILIS, FOR DONOR SAMPLES. THE DONOR BLOOD SCREENING WAS PERFORMED ON THE ARCHITECT SYSTEM AND, LATER IN THE STUDY, THE ALINITY I SYSTEM. A RETROACTIVE STUDY WAS PERFORMED FOR DONOR SAMPLES COLLECTED BETWEEN NOVEMBER 2019 AND NOVEMBER 2024. DONOR SAMPLE RESULTS FOR HBSAG, ANTI-HBC, HCV ANTIBODY, HIV ANTIGEN/ANTIBODY COMBO, HTLV ANTIBODY, AND SYPHILIS ANTIBODY WERE COLLECTED FOR INITIAL SCREENING, REPEAT 1 AND 2 TESTS, AS WELL AS NAT RESULTS FOR HIV, HCV, AND HBV. A TOTAL OF 48,241 BLOOD DONATIONS, WITH 38,562 UNIQUE DONORS, WERE TESTED. INITIAL SCREENING RESULTS WERE INTERPRETED AS REACTIVE (S/CO = 1.0), GREY ZONE (0.90 = S/CO < 1.0), OR NONREACTIVE (S/CO < 0.90) WITH REPEAT TESTING PERFORMED FOR SAMPLES WITH AN INTERPRETATION OF GREY ZONE OR REACTIVE. THE FOLLOWING INFORMATION WAS PROVIDED: 76 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HBC, OF WHICH 24 REPEATED AS REACTIVE. 28 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HBSAG, OF WHICH 8 REPEATED AS REACTIVE. 39 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HCV, OF WHICH 11 REPEATED AS REACTIVE. 20 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HTLV, OF WHICH 3 REPEATED AS REACTIVE. 36 DONOR SAMPLES HAD INITIAL RESULT IN GREY ZONE FOR SYPHILIS, OF WHICH 11 REPEATED REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE BY WAJNAT A. TOUNSI, ET.AL., ¿THE ¿GREY ZONE¿ IN BLOOD DONOR SCREENING: A RETROSPECTIVE STUDY AND PROPOSAL FOR DONOR RE-ENTRY¿, DIAGNOSTICS 2025, 15, 2261. MDPI AG, DOCUMENTED FALSE NONREACTIVE ANTI-HBC, HBSAG, ANTI-HCV, HTLV, AND SYPHILIS, FOR DONOR SAMPLES. THE DONOR BLOOD SCREENING WAS PERFORMED ON THE ARCHITECT SYSTEM AND, LATER IN THE STUDY, THE ALINITY I SYSTEM. A RETROACTIVE STUDY WAS PERFORMED FOR DONOR SAMPLES COLLECTED BETWEEN NOVEMBER 2019 AND NOVEMBER 2024. DONOR SAMPLE RESULTS FOR HBSAG, ANTI-HBC, HCV ANTIBODY, HIV ANTIGEN/ANTIBODY COMBO, HTLV ANTIBODY, AND SYPHILIS ANTIBODY WERE COLLECTED FOR INITIAL SCREENING, REPEAT 1 AND 2 TESTS, AS WELL AS NAT RESULTS FOR HIV, HCV, AND HBV. A TOTAL OF 48,241 BLOOD DONATIONS, WITH 38,562 UNIQUE DONORS, WERE TESTED. INITIAL SCREENING RESULTS WERE INTERPRETED AS REACTIVE (S/CO = 1.0), GREY ZONE (0.90 = S/CO < 1.0), OR NONREACTIVE (S/CO < 0.90) WITH REPEAT TESTING PERFORMED FOR SAMPLES WITH AN INTERPRETATION OF GREY ZONE OR REACTIVE. THE FOLLOWING INFORMATION WAS PROVIDED: 76 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HBC, OF WHICH 24 REPEATED AS REACTIVE. 28 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HBSAG, OF WHICH 8 REPEATED AS REACTIVE. 39 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR ANTI-HCV, OF WHICH 11 REPEATED AS REACTIVE. 20 DONOR SAMPLES HAD INITIAL RESULTS IN GREY ZONE FOR HTLV, OF WHICH 3 REPEATED AS REACTIVE. 36 DONOR SAMPLES HAD INITIAL RESULT IN GREY ZONE FOR SYPHILIS, OF WHICH 11 REPEATED REACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335336 ARCHITECT SYPHILIS TP ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 00380740155438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I1000SR MOD, 01L86-01, 117UNKNOWND11| ARC I1000SR MOD, 01L86-01, 117UNKNOWND11