BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TSHR

    MDR report key: 24134137 · Received January 21, 2026

    Report

    Report Number
    1823260-2026-00233
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    November 17, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    UDI-DI
    07613336160329
    PMA / PMN Number
    K193313
    Removal / Correction Number
    RES 98103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE ANALYZER'S SERIAL NUMBER IS (B)(6). ISSUES HAVE BEEN IDENTIFIED WITH THE ELECSYS ANTI-TSHR ASSAY, PARTICULARLY AROUND THE 1.75 IU/L MEDICAL DECISION POINT. ROCHE DIAGNOSTICS HAS ISSUED AN URGENT MEDICAL DEVICE CORRECTION FOR THIS ISSUE, ENTITLED "ELECSYS® ANTI-TSHR ASSAY ¿ DEVIATIONS ON COBAS® E 411, 402, AND 801 ANALYZERS." THIS CORRECTION HAS BEEN REPORTED TO FDA. ROCHE DIAGNOSTICS INVESTIGATED AND CONFIRMED THE CUSTOMERS' ALLEGATIONS. THE ROOT CAUSE FOR THE VARIATIONS IN THE ELECSYS ANTI-TSHR ASSAY WAS AN INSUFFICIENCY OF THE ASSAY'S ROUTINE PRODUCTION PROCESS. FOR THE PLATFORM-TO-PLATFORM DEVIATION (COBAS E 411 VS. COBAS E 402/E 801), DIFFERENCES AROSE DUE TO AN INSUFFICIENT ALIGNMENT CONCEPT BETWEEN THE PLATFORMS. THESE VARIATIONS WERE FURTHER INFLUENCED BY UPDATES TO THE ROUTINE PRODUCTION PROCESS FOR THIS ASSAY. FOR THE LOT-TO-LOT DEVIATION ON E 411, MEASURES TAKEN TO ENHANCE ROBUSTNESS LED TO ADDITIONAL SHIFTS. CUSTOMERS WERE ADVISED TO IMMEDIATELY DISCONTINUE USING AND DISCARD THE AFFECTED LOT NUMBERS: 840183 AND 874011 ON THE COBAS E402/E801 ANALYZER 840177 ON THE COBAS E411 ANALYZER. CUSTOMERS WERE ADVISED TO SWITCH TO THE NEW UNAFFECTED LOT NUMBERS: 908953 ON THE COBAS E402/E801 ANALYZER 906872 ON THE COBAS E411 ANALYZER. THE COBAS E601 AND E602 MODULES ARE NOT AFFECTED AND CAN BE USED WITH ALL CURRENTLY AVAILABLE LOTS AND WITH THE UPCOMING LOTS WITHOUT RESTRICTIONS.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 1.24 IU/L. BETWEEN APPROXIMATELY (B)(6) 2025, THE REPEATED RESULT WAS 1.94 IU/L. PATIENT 2: THE INITIAL RESULT WAS 1.61 IU/L. BETWEEN APPROXIMATELY (B)(6) 2025, THE REPEATED RESULT WAS 2.32 IU/L. PATIENT 3: THE INITIAL RESULT WAS 1.46 IU/L. THE REPEATED RESULT WAS 2.04 IU/L. THE REPEATED RESULTS WERE OBTAINED ON A DIFFERENT MODULE (COBAS E602) USING A DIFFERENT ELECSYS ANTI-TSHR REAGENT LOT NUMBER (LOT 840177).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191851 ELECSYS ANTI-TSHR THYROID AUTOANTIBODY TEST JZO ROCHE DIAGNOSTICS 840183 07613336160329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown