BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I RUBELLA IGG REAGENT KIT

    MDR report key: 24337838 · Received February 13, 2026

    Report

    Report Number
    3008344661-2026-00036
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    September 27, 2025
    Report Date
    February 23, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFX
    UDI-DI
    00380740131302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I RUBELLA IGG ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 73122FZ00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I RUBELLA IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 73122FZ00 FOR NONREACTIVE RESULTS IS COMPARABLE WITH OTHER LOTS IN THE FIELD, INCLUDING LOT 78495FZ00, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. IN-HOUSE SPECIFICITY TESTING WAS PERFORMED USING A RETAINED KIT OF LOT 73122FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I RUBELLA IGG REAGENT LOT 73122FZ00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P46 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4W02-22, WITH 510K NUMBER K243168. 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 OBSERVED A FALSE POSITIVE ALINITY I RUBELLA IGG FOR ONE PREGNANT PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL RUBELLA IGG RESULT= 39.26 IU/ML (POSITIVE); THE PATIENT RETURNED ON (B)(6) 2025 AND THE RESULT WAS NEGATIVE. THE STORED SEPTEMBER SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I RUBELLA IGG FOR ONE PREGNANT PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025, SID (B)(6), INITIAL RUBELLA IGG RESULT= 39.26 IU/ML (POSITIVE); THE PATIENT RETURNED ON (B)(6) 2025 AND THE RESULT WAS NEGATIVE. THE STORED SEPTEMBER SAMPLE WAS REPEATED AND THE RESULT WAS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400972 ALINITY I RUBELLA IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA LFX ABBOTT IRELAND DIAGNOSTICS DIVISION 73122FZ00 00380740131302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)