Elecsys Anti-TSHR 08496609190Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07613336160305), received between Dec 17, 2021 and Apr 20, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “High Test Results” (17 reports).

1 other recall cover devices cleared under the same FDA submission (K193313); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FOR QUALITY CONTROL MATERIAL AND PATIENT SAMPLES FROM THE COBAS E411 RACK ANALYZER. THE CUSTOMER ALLEGED AN INCREASED NUMBER OF CONSPICUOUSLY BORDERLINE POSITIVE PATIENT RESULTS, RANGING FROM 1.80 U/L TO 3.26 U/L, WHICH WERE DISCREPANT FROM CLINICAL EXPECTATIONS. SPECIFIC RESULTS COMPARISONS WERE PROVIDED. THE REPEAT TESTING WAS PERFORMED USING A DIFFERENT COBAS E411 ANALYZER. SAMPLE 1 INITIAL RESULT WAS 1.91 U/L, AND THE REPEAT RESULT WAS 1.02 U/L. SAMPLE 2 INITIAL RESULT WAS 2.14 U/L, AND THE REPEAT RESULT WAS 1.3 U/L. SAMPLE 3 INITIAL RESULT WAS 4.74 U/L, AND THE REPEAT RESULT WAS 3.57 U/L. SAMPLE 4 INITIAL RESULT WAS 3.26 U/L, AND THE REPEAT RESULT WAS 2.45 U/L. SAMPLE 5 INITIAL RESULT WAS 2.36 U/L, AND THE REPEAT RESULT WAS 1.4 U/L. SAMPLE 6 INITIAL RESULT WAS 3.19 U/L, AND THE REPEAT RESULT WAS 2.3 U/L. SAMPLE 7 INITIAL RESULT WAS 2.56 U/L, AND THE REPEAT RESULT WAS 1.62 U/L. SAMPLE 8 INITIAL RESULT WAS 2.91 U/L, AND THE REPEAT RESULT WAS 1.95 U/L.

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

  MAUDE report 23485264 ↗
• MalfunctionNov 5, 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 RESULTS FROM COBAS E411 DISK ANALYZER. ONE EXAMPLE WAS AN INITIAL RESULT OF 3.3 IU/L. THE REPEAT RESULT AFTER RE-CENTRIFUGATION WAS 2.9 IU/L. THE RESULT FROM AN OUTSOURCED LABORATORY USING ALINITY WAS 1.8 IU/L. THE CUSTOMER PERFORMED COMPARISONS WITH THE OUTSOURCED LABORATORY USING ALINITY. SAMPLE 1: E411 RESULT WAS 2.9 IU/L, AND THE ALINITY RESULT WAS 1.7 IU/L. SAMPLE 2: E411 RESULT WAS 2.4 IU/L, AND THE ALINITY RESULT WAS 0.8 IU/L. SAMPLE 3: E411 RESULT WAS 2.2 IU/L, AND THE ALINITY RESULT WAS <0.8 IU/L. SAMPLE 4: E411 RESULT WAS 3.8 IU/L, AND THE ALINITY RESULT WAS 2.3 IU/L. SAMPLE 5: E411 RESULT WAS 2.4 IU/L, AND THE ALINITY RESULT WAS 0.9 IU/L. SAMPLE 6: E411 RESULT WAS 2.0 IU/L, AND THE ALINITY RESULT WAS <0.8 IU/L. SAMPLE 7: E411 RESULT WAS 7.1 IU/L, AND THE ALINITY RESULT WAS 4.6 IU/L. SAMPLE 8: E411 RESULT WAS 2.5 IU/L, AND THE ALINITY RESULT WAS 1.3 IU/L. SAMPLE 9: E411 RESULT WAS 2.0 IU/L, AND THE ALINITY RESULT WAS <0.8 IU/L. SAMPLE 10: E411 RESULT WAS 2.3 IU/L, AND THE ALINITY RESULT WAS 1.1 IU/L. PATIENT "A" E411 RESULTS WERE 4.6 IU/L AND 4.1 IU/L. THE RESULT USING ALINITY WAS 2.8 IU/L. PATIENT "B" E411 RESULTS

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

  MAUDE report 23477119 ↗
• MalfunctionOct 29, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FOR MULTIPLE PATIENT SAMPLES ON A COBAS E411 MODULE. THE CUSTOMER PROVIDED EXAMPLES OF RESULTS FOR 4 PATIENT SAMPLES. THE CUSTOMER QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE CLINICAL PICTURES OF THE PATIENTS. FOR SAMPLE 1, THE RESULT WAS 1.7 IU/L. FOR SAMPLE 2, THE RESULT WAS 1.8 IU/L. FOR SAMPLE 3, THE RESULT WAS 1.6 IU/L. FOR SAMPLE 4, THE RESULT WAS 5 IU/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416580 ↗
• MalfunctionOct 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). THE REPORTER STATED THAT AFTER SWITCHING TO A NEW CALIBRATOR LOT FOR THE ASSAY, THEY NOTED A SIGNIFICANT INCREASE IN QC RECOVERY AND PATIENT RESULTS. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE INITIAL RESULT FROM THE ANALYZER USING THE CALIBRATION FROM THE NEW CALIBRATOR LOT WAS 2.06 IU/L. THE REPEAT RESULT FROM ANOTHER ANALYZER USING THE CALIBRATION FROM THE OLD CALIBRATOR LOT WAS 1.43 IU/L. THE DOCTOR QUESTIONED THE INITIAL RESULT, PROMPTING THE RERUN.

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

  MAUDE report 23416143 ↗
• MalfunctionOct 21, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS ANTI-TSHR (ANTI-TSHR) ON A COBAS E 411 ANALYZER (RACK SYSTEM) SINCE (B)(6) 2025. THE FOLLOWING EXAMPLES FOR 2 PATIENT SAMPLES TESTED ON (B)(6) 2025 WERE PROVIDED. PATIENT 1 RESULT FROM THE E411 ANALYZER WAS 1.75 U/L. THE RESULT AT ANOTHER LABORATORY USING AN UNSPECIFIED COBAS 8000 SYSTEM WAS 0.88 U/L. PATIENT 2 RESULT FROM THE E411 ANALYZER WAS 2.75 U/L. THE RESULT AT ANOTHER LABORATORY USING AN UNSPECIFIED COBAS 8000 SYSTEM WAS < 0.8 U/L. THE FIELD APPLICATION SPECIALIST (FAS) FOUND THAT QC WAS INITIALLY ACCEPTABLE BUT SHIFTED AFTER REPLACING THE REAGENT AND PERFORMING CALIBRATION. LIQUID FLOW CLEANING (LFC) AND MEASURING CELL PREPARATION WERE PERFORMED. CALIBRATION AND QC WERE COMPLETED, AND PATIENT SAMPLES WERE RUN. THE ISSUE WAS NOT RESOLVED. QC WAS WITHIN RANGE BUT WAS TRENDING HIGH. PATIENT RESULTS WERE ALSO HIGH. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT QC FOR SOME TESTS WAS OUTSIDE OF THE ACCEPTABLE RANGE. THE MEASURING CELL WAS REPLACED. A CELL BLANK AND CALIBRATIONS WERE COMPLETED. AFTER THE MEASURING CELL WAS REPLACED, THE CUSTOMER

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

  MAUDE report 23349700 ↗
• MalfunctionOct 17, 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 DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH TWO DIFFERENT LOT NUMBERS OF ELECSYS ANTI-TSHR REAGENT ON COBAS E411 DISK ANALYZERS. THE FIRST PATIENT SAMPLE WAS TESTED ON E411 ANALYZER #1 WITH REAGENT LOT 840177, RESULTING IN ANTI-TSH VALUES OF 1.9 IU/L ON (B)(6) 2025 AND 2.49 IU/L ON (B)(6) 2025. THE PATIENT SAMPLE WAS TESTED ON E411 ANALYZER #2, RESULTING IN ANTI-TSH VALUES OF 2.3 IU/L ON (B)(6) 2025 AND 2.69 IU/L ON (B)(6) 2025. THE SECOND PATIENT SAMPLE WAS TESTED ON E411 ANALYZER #1 WITH REAGENT LOT 840177, RESULTING IN ANTI-TSH VALUES OF 2.9 IU/L ON (B)(6) 2025 AND 3.35 IU/L ON (B)(6) 2025. THE PATIENT SAMPLE WAS TESTED ON E411 ANALYZER #2, RESULTING IN ANTI-TSH VALUES OF 3.3 IU/L ON (B)(6) 2025 AND 3.61 IU/L ON (B)(6) 2025. THE SAMPLES WERE PROVIDED FOR INVESTIGATION WHERE THEY WERE TESTED WITH TWO DIFFERENT REAGENT AND CALIBRATOR LOTS ON E411 ANALYZER #3 ON (B)(6) 2025. DURING THE INVESTIGATION, THE FIRST SAMPLE WAS TESTED AFTER CALIBRATION WITH CALIBRATOR LOT 815555, RESULTING IN A VALUE OF 1.64 IU/L WITH REAGENT LOT 801930 AND 1.57 IU/L WITH REAGENT LOT 840177. THIS SAMPLE WAS TESTED AFTER CALIBRATION WITH CALIBRATOR LOT 8

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

  MAUDE report 23323837 ↗
• MalfunctionAug 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM 31 PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE REPORTER STATED THAT THE HIGH RESULTS DO NOT CORRESPOND WITH THE CLINICAL PICTURE. THE PATIENT SAMPLES WERE RERUN USING A PREVIOUS ELECSYS ANTI-TSHR REAGENT LOT AND A COMPETITOR ANALYZER (SIEMENS IMMULITE). PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE EXAMPLES OF DISCREPANT RESULTS.

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

  MAUDE report 22848868 ↗
• MalfunctionJun 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-TSHR (ANTI-TSHR) ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT FROM THE E411 ANALYZER WAS 2.83 IU/L. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY, WHERE THE RESULT FROM AN UNSPECIFIED METHOD WAS < 0.80 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167965 ↗
• MalfunctionApr 3, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM THREE PATIENT SAMPLES TESTED ON TWO COBAS E411 RACK ANALYZERS (COBAS 1 AND COBAS 2). THE REPORTER STATED THAT THE ANALYZERS' RESULTS WOULD STRAY ACROSS THE CUTOFF VALUE, RESULTING IN A POSITIVE RESULT FROM THE INITIAL RUN AND A NEGATIVE RESULT FROM THE RERUN. ONE PATIENT SAMPLE WITH DISCREPANT RESULTS WAS PROVIDED: THE REPORTER WAS UNABLE TO PROVIDE THE SPECIFIC DATE FOR THE EVENT AND ONLY STATED THAT THE EVENT WAS IN THE PAST. THE INITIAL RESULT FROM COBAS 1 WAS 2.2 IU/L. THE REPEAT RESULT FROM COBAS 2 WAS 1.6 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761363 ↗
• MalfunctionSep 20, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR IMMUNOASSAY RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. THE REPORTER STATED THAT THEY DID NOT HAVE THE ANTI-TSHR TEST DISABLED IN THE MODULE WHEN THE INITIAL DAILY SAMPLE TUBES WERE TESTED. THE REPORTER QUESTIONED THE DIFFERENCE IN RESULTS WHEN THE FROZEN SAMPLE TUBE (SPECIFIC TUBE THEY USE FOR THE ASSAY) FROM THE SAME COLLECTION WAS PROCESSED. FOR SAMPLE 1, THE INITIAL ANTI-TSHR RESULT WAS 1.35 IU/L. THE REPEAT RESULT FROM THE FROZEN SAMPLE WAS 8.88 IU/L. FOR SAMPLE 2, THE INITIAL ANTI-TSHR RESULT WAS 1.12 IU/L. THE REPEAT RESULT FROM THE FROZEN SAMPLE WAS 7.92 IU/L. THE FROZEN SAMPLE RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267086 ↗
• MalfunctionJul 25, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TSHR ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (RACK SYSTEM). INITIAL RESULT: 37.98 IU/L. THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY AND THE SAME SAMPLE WAS THEN REPEATED ON THE SAME ANALYZER ON (B)(6) 2024. REPEAT RESULT: 1.75 IU/L. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827536 ↗
• MalfunctionFeb 9, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM 20 PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT, COBAS 6000 E601 MODULE, AND COBAS PURE E 402 ANALYTICAL UNIT. THIS MDR IS FOR THE ANTI-TSHR USED IN THE E 601 ANALYZER. PLEASE REFER TO MDR WITH A1. PATIENT IDENTIFIER PT-0066710 FOR THE ANTI-TSHR USED IN THE E 801 AND E 402 ANALYZERS. THE REPORTER STATED THAT THEY CHANGED THEIR ANALYZER FROM A COBAS E601 TO A COBAS E 801 AND FOUND THAT THE ANTI-TSHR RESULTS TENDED TO BE LOWER ON THE E 801. THE REPORTER WAS NOT ABLE TO STATE WHICH RESULTS WERE DEEMED CORRECT. THE CLINICIAN QUESTIONED THE REASON FOR THE DISCREPANCY. THE REPORTER WAS ABLE TO PROVIDE SEVEN PATIENT SAMPLES WITH DISCREPANT RESULTS. PLEASE REFER TO THE ATTACHMENT PT-0066710 FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676124 ↗
• MalfunctionNov 15, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE THYROID RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE. FOR THE PRELIMINARY INVESTIGATION, THE SAMPLE WAS RETESTED ON A DIFFERENT COBAS E601 MODULE AND AN ABBOTT ARCHITECT ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH IS FOR THE ELECSYS ANTI-TSHR ASSAY. REFER TO THE MEDWATCHS LISTED BELOW FOR THE ADDITIONAL INVOLVED ASSAYS. MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE FT3 G3 ELECSYS ASSAY. MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS FT4 IV ASSAY. MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS ANTI-TG ASSAY. MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS ANTI-TPO ASSAY. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144650 ↗
• MalfunctionNov 3, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TSHR ON A COBAS 6000 E601 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN ANTI-TSHR VALUE OF > 40.00 IU/L WITH A DATA FLAG. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 1.45 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067006 ↗
• MalfunctionSep 21, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER COMPARED TO COMPETITOR METHODS. DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS FT4 IV (FT4 IV), ELECSYS FT3 III (FT3 III), AND ELECSYS ANTI-TSHR (ANTI-TSHR) BETWEEN THE CUSTOMER¿S E411 ANALYZER, THE ABBOTT ALINITY METHOD, THE FUJIREBIO LUMIPULSE METHOD AND AN E411 ANALYZER USED AT THE INVESTIGATION SITE. THIS MEDWATCH WILL COVER ANTI-TSHR. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 IV RESULTS. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789409 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193313. One submission often covers many models, so check the product and lot details in each record.

• Z-1009-2026 · Nov 21, 2025 · Open, Classified
  The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is i