Elecsys Anti-TSHRRecalls & reported problems across all models

We found 3 models of Elecsys Anti-TSHR by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Jul 31, 2026 — classified as 53 malfunctions.

The most frequently reported specific device problem is “High Test Results” (28 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Elecsys Anti-TSHR problems

Elecsys Anti-TSHR models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Elecsys Anti-TSHR 08496609190

  SYSTEM, TEST, THYROID AUTOANTIBODY
  31 reports
• Elecsys Anti-TSHR 08496633190

  SYSTEM, TEST, THYROID AUTOANTIBODY
  16 reports
• Elecsys Anti-TSHR 07026951190

  SYSTEM, TEST, THYROID AUTOANTIBODY
  6 reports

Recent Elecsys Anti-TSHR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50097795 ↗
• MalfunctionApr 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS ANTI-TSHR (ANTI-TSHR) ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULTS WERE GENERATED WITH REAGENT LOT 84017701, EXPIRATION DATE 31-MAY-2026. THE REPEAT RESULTS WERE GENERATED WITH REAGENT LOT 906872, EXPIRATION DATE 28-FEB-2027. "PATIENT 2" INITIAL RESULT WAS 4.23 IU/L. THE REPEAT RESULT WAS 0.825 IU/L. PATIENT 3 INITIAL RESULT WAS 16.6 IU/L. THE REPEAT RESULT WAS 11.01 IU/L.

  Patient problems: Hyperthyroidism

  MAUDE report 24924354 ↗
• MalfunctionMar 2, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE PATIENT'S RESULTS HAVE BEEN SIGNIFICANTLY ELEVATED AND DO NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. ONE ANTI-TSHR RESULT OF 25.50 IU/L WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489371 ↗
• MalfunctionFeb 24, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TSHR ASSAY ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 2.4 IU/L. THE 1ST REPEAT RESULT WAS 2.5 IU/L. THE CUSTOMER'S RESULTS WERE INTERPRETED AS POSITIVE FOR ANTI-TSHR; THE PATIENT DOES NOT HAVE GRAVES¿ DISEASE-LIKE SYMPTOMS. THE SAMPLE WAS SENT TO AN OUTSOURCED LABORATORY AND REPEATED ON A COBAS E 801 ANALYZER. THE 2ND REPEAT RESULT WAS 1.4 IU/L AND INTERPRETED AS NEGATIVE FOR ANTI-TSHR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434269 ↗
• MalfunctionFeb 24, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM THE COBAS 6000 E601 MODULE. WHILE PERFORMING A RETROSPECTIVE ANALYSIS OF ANTI-TSHR RESULTS GENERATED IN THIS LABORATORY IN 2025, THE CUSTOMER FOUND A HIGH PERCENTAGE (>50%) HAD REACTIVE/HIGH VALUES >1.75 U/ML. THE CUSTOMER ALLEGED THIS IS IMPLAUSIBLE AS THE PATIENT POPULATION IS AN "OBVIOUSLY HEALTHY, ROUTINE PATIENT COLLECTIVE". THE PROVIDED INITIAL RESULT EXAMPLES RANGED FROM 1.75 U/ML TO >400 U/ML. REPEAT TESTING OR COMPARISON DATA FOR THE SAMPLES WAS REQUESTED BUT HAS NOT YET BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428131 ↗
• MalfunctionJan 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  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).

  Patient problems: Hyperthyroidism

  MAUDE report 24134137 ↗
• MalfunctionDec 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FOR QC MATERIAL AND PATIENT SAMPLES FROM THE COBAS E 801 ANALYTICAL UNIT. FOR ONE PATIENT, THE INITIAL RESULT WAS 4.7 IU/L. ON (B)(6) 2025, THE REPEAT RESULTS USING A NEW REAGENT CASSETTE OF THE SAME LOT NUMBER WERE 3.0-3.2 IU/L.

  Patient problems: Hyperthyroidism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876444 ↗
• MalfunctionDec 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV, ELECSYS FT3 III, AND ELECSYS ANTI-TSHR RESULTS FOR 1 PATIENT COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: ON (B)(6) 2022, THE INITIAL FT4 RESULT WAS 1.72 NG/DL, AND THE REPEATED RESULT USING ANOTHER METHOD (CLIA ASSAY) IN ANOTHER LABORATORY WAS 1.03 NG/DL. THE INITIAL FT3 RESULT WAS 3.98 PG/ML, AND THE REPEATED RESULT USING ANOTHER METHOD (CLIA ASSAY) IN ANOTHER LABORATORY WAS 2.81 PG/ML. SAMPLE 2: ON (B)(6) 2025, THE ANTI-TSHR RESULT IS 2.9 IU/L. IT WAS ALLEGED THAT THE ANTI-TSHR RESULT WAS FALSELY ELEVATED, AND AN INTERFERENCE WITH THE ELECSYS ANTI-TSHR ASSAY WAS SUSPECTED. THIS MEDWATCH WILL APPLY TO THE ELECSYS ANTI-TSHR ASSAY. FOR SAMPLE 1 RESULTS OBTAINED ON (B)(6) 2022: PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FT4 IV ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FT3 III ASSAY.

  Patient problems: Hyperthyroidism

  MAUDE report 23863556 ↗
• MalfunctionDec 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR ASSAY RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES TESTED ON A COBAS E 411 ANALYZER (RACK SYSTEM) COMPARED TO A DIFFERENT METHOD. IT WAS REPORTED THAT SAMPLES WERE INITIALLY POSITIVE, AND WHEN REPEATED USING A DIFFERENT METHOD AT ANOTHER LABORATORY AND THE RESULTS WERE NEGATIVE. THE FOLLOWING EXAMPLE RESULTS WERE PROVIDED FOR A PATIENT SAMPLE: ON (B)(6) 2025: 1.90 IU/L (ACCOMPANIED BY A DATA FLAG), (B)(6) 2025: CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA): 1.56 UI/L (NEGATIVE), (B)(6) 2025: 2.33 IU/L (ACCOMPANIED BY A DATA FLAG).

  Patient problems: Hypothyroidism

  MAUDE report 23717413 ↗
• MalfunctionDec 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE HIGH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS ANTI-TSHR ABOVE THE CUT-OFF VALUE OF 1.75 IU/L. THE CUSTOMER COMPLAINED THAT THE VALUES ARE TOO HIGH AS THEY DO NOT MATCH THE CLINICAL STATUS OF THE PATIENTS. THE CUSTOMER PROVIDED SPECIFIC DATA FOR 3 PATIENT SAMPLES. SAMPLE 1 HAD AN INITIAL RESULT OF 1.86 IU/L FROM AN E 411 ANALYZER. THE SAMPLE WAS REPEATED ON AN E 601 ANALYZER AND THE RESULT WAS 1.10 IU/L. SAMPLE 2 HAD AN INITIAL RESULT OF 1.99 IU/L FROM AN E 411 ANALYZER. THE SAMPLE WAS REPEATED ON AN E 601 ANALYZER AND THE RESULT WAS 1.07 IU/L. SAMPLE 3 HAD AN INITIAL RESULT OF 2.11 IU/L FROM AN E 411 ANALYZER. THE SAMPLE WAS REPEATED ON AN E 601 ANALYZER AND THE RESULT WAS 1.06 IU/L.

  Patient problems: Hyperthyroidism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23688786 ↗
• MalfunctionNov 26, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 0.800 IU/L. THE REPEAT RESULT WAS 23.83 IU/L. THIS RESULT WAS CONSISTENT WITH THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656210 ↗
• MalfunctionNov 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLY HIGH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS ANTI-TSHR ON A COBAS E411 RACK. THE RESULTS DO NOT AGREE WITH THE CLINICAL CONDITION OF THE PATIENTS. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THE CUSTOMER STATED THEY NOTICED A SHIFT UPWARD IN PATIENT RESULTS SINCE MID (B)(6) 2025 WHEN USING REAGENT LOT 840177 IN COMBINATION WITH CALIBRATOR LOT 849155. THE PATIENT RESULTS RECOVER ABOVE THE NORMAL CUTOFF OF 1.75 IU/L IN PATIENTS WITH AN OTHERWISE EUTHYROID METABOLIC STATE. FOR EXAMPLE, A PATIENT SAMPLE WILL RECOVER A SLIGHTLY ELEVATED VALUE OF 2.2 IU/L.

  Patient problems: Hyperthyroidism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23635053 ↗
• MalfunctionNov 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 2.17 U/L. THE REPEAT RESULT WAS 1.41 U/L.

  Patient problems: Hyperthyroidism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544153 ↗
• MalfunctionNov 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE HIGH RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS ANTI-TSHR. THE DOCTORS COMPLAIN THAT THE VALUES ARE TOO HIGH AS THEY DO NOT MATCH THE CLINICAL STATUS OF THE PATIENTS OR THE PREVIOUS VALUES FROM THE PATIENTS. THE CUSTOMER PROVIDED SPECIFIC DATA FOR SIX PATIENT SAMPLES. NO UNITS OF MEASURE WERE PROVIDED. THE FIRST SAMPLE RESULTED IN AN ANTI-TSHR VALUE OF 2.21. THE SECOND SAMPLE RESULTED IN AN ANTI-TSHR VALUE OF 1.87. THE THIRD SAMPLE RESULTED IN AN ANTI-TSHR VALUE OF 1.96. THE FOURTH SAMPLE RESULTED IN AN ANTI-TSHR VALUE OF 1.85. THE FIFTH SAMPLE RESULTED IN AN ANTI-TSHR VALUE OF 2.43. THE SIXTH SAMPLE RESULTED IN AN ANTI-TSHR VALUE OF 2.39.

  Patient problems: Hyperthyroidism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534841 ↗
• MalfunctionNov 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS E411 MODULE. THE CUSTOMER PROVIDED AN EXAMPLE OF DISCREPANT RESULTS FOR 15 PATIENT SAMPLES TESTED. THE CUSTOMER ALLEGED AN INCREASED NUMBER OF CONSPICUOUSLY BORDERLINE POSITIVE PATIENTS, AND THAT THE RESULTS DID NOT MATCH THE MEDICAL DOCTOR'S EXPECTATIONS FOR THE PATIENTS' RESULTS. FOR SAMPLE 1, THE RESULT WAS 10.56 IU/L. FOR SAMPLE 2, THE RESULT WAS 1.95 IU/L. FOR SAMPLE 3, THE RESULT WAS 1.96 IU/L. FOR SAMPLE 4, THE RESULT WAS 1.88 IU/L. FOR SAMPLE 5, THE RESULT WAS 2.27 IU/L. FOR SAMPLE 6, THE RESULT WAS 1.70 IU/L. FOR SAMPLE 7, THE RESULT WAS 2.13 IU/L. FOR SAMPLE 8, THE RESULT WAS 2.08 IU/L. FOR SAMPLE 9, THE RESULT WAS 2.16 IU/L. FOR SAMPLE 10, THE RESULT WAS 1.71 IU/L. FOR SAMPLE 11, THE RESULT WAS 1.93 IU/L. FOR SAMPLE 12, THE RESULT WAS 2.22 IU/L. FOR SAMPLE 13, THE RESULT WAS 1.89 IU/L. FOR SAMPLE 14, THE RESULT WAS 1.65 IU/L. FOR SAMPLE 15, THE RESULT WAS 1.42 IU/L.

  Patient problems: Hyperthyroidism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23512419 ↗

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