cobas Elecsys AntiTPO 6368590190Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04015630929702), received between Jul 20, 2018 and Feb 3, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K051890); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026High Test Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TPO ASSAY ON A COBAS 6000 E601 MODULE. INITIAL RESULT: 127 IU/ML. THE CUSTOMER NOTICED THAT THE INITIAL RESULT WAS HIGH AND REPEATED THE SAMPLE. ON (B)(6) 2026: 1ST REPEAT RESULT: 50 IU/ML. 2ND REPEAT RESULT: 23 IU/ML (TESTED AFTER CALIBRATION). ON (B)(6) 2026, A NEW REAGENT PACK WAS USED: THE ORIGINAL SAMPLE WAS RE-TESTED: 3RD REPEAT RESULT: <5 IU/ML. A NEW SAMPLE WAS DRAWN AND TESTED, RESULTING IN A VALUE OF <5 IU/ML. THE REPEAT RESULT OF 23 IU/ML WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250305 ↗
• MalfunctionFeb 19, 2025No Device Output; Incorrect, Inadequate or Imprecise Result or Readings; No Device Output; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER QUESTIONED DILUTION RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-TPO (ANTI-TPO) ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS > 600 IU/ML. THE SAMPLE WAS REPEATED WITH DILUTION AND THE RESULT WAS 74.70 IU/ML (CALCULATED RESULT 448.2 IU/ML). ON (B)(6)2025 THE SAMPLE WAS RUN WITH NO DILUTION AND THE RESULT WAS > 600 IU/ML. THE SAMPLE WAS REPEATED WITH DILUTION TWICE WITH RESULTS OF 69.99 IU/ML (CALCULATED RESULT 419.94 IU/ML) AND 89 IU/ML (CALCULATED RESULT 445 IU/ML). THE CUSTOMER QUESTIONED WHY THE DILUTED RESULTS WERE LOWER THAN THE UNDILUTED RESULTS OF > 600 IU/ML. ON (B)(6)2025 THE CUSTOMER REPEATED THE SAMPLE USING A NEW DILUENT AND THE RESULT WITH AN X5 DILUTION WAS 101.2 IU/ML (CALCULATED RESULT 506 IU/ML). ON (B)(6)2025 THE CUSTOMER PERFORMED ADDITIONAL DILUTIONS WITH THE FOLLOWING RESULTS: 1:2 DILUTION WAS 314.3 IU/ML (CALCULATED RESULT 628.6 IU/ML). 1:8 DILUTION WAS 114.0 IU/ML (CALCULATED RESULT 912.4 IU/ML). 1:20 DILUTION WAS 33.33 IU/ML (CALCULATED RESULT 666.6 IU/ML). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412043 ↗
• MalfunctionJan 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TPO RESULTS FROM ONE PATIENT SAMPLE TESTED ON THREE COBAS PURE E 402 ANALYTICAL UNITS AND TWO COBAS E411 ANALYZERS. THIS MEDWATCH IS FOR THE COBAS E 411 ANALYZER ELECSYS ANTI-TPO REAGENT. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE COBAS PURE E 402 ANALYTICAL UNIT ELECSYS ANTI-TPO REAGENT. ON (B)(6) 2024: THE INITIAL RESULT FROM THE FIRST E 402 ANALYZER WAS 250 IU/ML OR 279.0 IU/ML. THE FIRST REPEAT RESULT FROM THE FIRST E 411 ANALYZER WAS 40.6 IU/ML OR 40 IU/ML. ON (B)(6) 2024: THE SECOND REPEAT RESULT FROM THE SECOND E 402 ANALYZER WAS 227 IU/ML. THE THIRD REPEAT RESULT FROM THE THIRD E 402 ANALYZER WAS 256 IU/ML. THE FOURTH REPEAT RESULT FROM THE SECOND E 411 ANALYZER WAS 48.86 WITH A DATA FLAG. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT DID NOT FIT THE CLINICAL PICTURE (THE PATIENT HAD PREVIOUS NORMAL RESULTS). THE REPORTER WAS UNSURE WHICH RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148862 ↗
• MalfunctionNov 4, 2024Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE FOR A TOTAL OF 12 PATIENT SAMPLES TESTED WITH ELECSYS ANTI-TPO ON A COBAS E411 DISK. EXAMPLES WERE PROVIDED FOR THREE PATIENT SAMPLES WITH DISCREPANT ANTI-TPO RESULTS. THE FIRST SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF > 600 IU/ML WITH A DATA FLAG AND IT REPEATED AS 16.72 IU/ML. THE SECOND SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 162 IU/ML AND IT REPEATED AS 74.97 IU/ML. THE THIRD SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 49.7 IU/ML AND IT REPEATED AS 16 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599173 ↗
• MalfunctionSep 6, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR "SEVERAL" PATIENT SAMPLES TESTED FOR ELECSYS ANTI-TPO (ANTI-TPO) ON A COBAS E 411 ANALYZER (DISK SYSTEM). FOLLOWING THE HIGH RESULTS, THE CUSTOMER RECALIBRATED THE REAGENT AND REPEATED THE PATIENT SAMPLES AND THE RESULTS WERE NOT REPRODUCIBLE. EXAMPLES OF DISCREPANT RESULTS WERE PROVIDED FOR 4 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS >600 IU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 180.0 IU/ML. PATIENT 2 INITIAL RESULT WAS 449.5 IU/ML. THE REPEAT RESULT WAS 16.94 IU/ML. PATIENT 3 INITIAL RESULT WAS 492.0 IU/ML. THE REPEAT RESULT WAS 14.41 IU/ML. PATIENT 4 INITIAL RESULT WAS 144.8 IU/ML. THE REPEAT RESULT WAS 13.09 IU/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157935 ↗
• MalfunctionJul 26, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH ELECSYS ANTI-TPO ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (RACK SYSTEM). INITIAL RESULT: >600.0 IU/ML (ACCOMPANIED BY A DATA FLAG AND CONSIDERED ABOVE THE MEASURING RANGE). THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE WAS THEN REPEATED. 1ST REPEAT RESULT: 10.22 IU/ML OBTAINED WITH A MANUAL DILUTION OF 1:5 AND, THEREFORE, MULTIPLIED BY THE FACTOR 5 THE FINAL RESULT WOULD BE 51.1 IU/ML. 2ND REPEAT RESULT: 18.76 IU/ML (NO DILUTION). NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE 2ND REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840644 ↗
• MalfunctionDec 7, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ANTI-TPO ELECSYS RESULTS FROM THE COBAS E411 DISK ANALYZER. PATIENT 1 INITIAL RESULT WAS 152.5 IU/ML WITH A DATA FLAG. THE REPEAT RESULT ON ANOTHER COBAS E411 WAS 50.68 IU/ML WITH A DATA FLAG AND REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT ON THE ORIGINAL ANALYZER WAS 48.68 IU/ML WITH A DATA FLAG. PATIENT 2 INITIAL RESULT WAS 151.2 IU/ML WITH A DATA FLAG. THE REPEAT RESULT ON ANOTHER COBAS E411 WAS 11.54 IU/ML AND REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT ON THE ORIGINAL ANALYZER WAS 13.57 IU/ML. PATIENT 3 INITIAL RESULT WAS 341.7 IU/ML WITH A DATA FLAG. THE REPEAT RESULT ON ANOTHER COBAS E411 WAS 19.91 IU/ML AND REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT ON THE ORIGINAL ANALYZER WAS 23.20 IU/ML WITH A DATA FLAG. PATIENT 4 INITIAL RESULT WAS 131.4 IU/ML WITH A DATA FLAG. THE REPEAT RESULT ON ANOTHER COBAS E411 WAS 59.11 IU/ML WITH A DATA FLAG AND REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT ON THE ORIGINAL ANALYZER WAS 69.04 IU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282355 ↗
• MalfunctionNov 16, 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-TPO 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-TSHR 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 18148003 ↗
• MalfunctionJan 9, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THAT CONTROLS WERE OUTSIDE OF RANGE FOR ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ON THE COBAS E 411 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). THEY ALSO RECEIVED QUESTIONABLE ANTI-TPO RESULTS FOR THREE PATIENT SAMPLES. NO PATIENT DATA WAS PROVIDED. THE AFFECTED SAMPLES INITIALLY RECOVERED POSITIVE ANTI-TPO VALUES AND THESE VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED AND RESULTED IN NEGATIVE ANTI-TPO VALUES THAT WERE OVER 30 % DIFFERENT FROM THE INITIAL VALUES. THE REPEATED VALUES WERE ALSO REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121064 ↗
• MalfunctionNov 4, 2022High 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 THE ELECSYS ANTI-TPO ASSAY ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE SAMPLE INITIALLY RESULTED IN A VALUE OF 600 IU/ML. THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN VALUES OF 9.3 IU/ML AND 10.7 IU/ML. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT OF 9.3 IU/ML WAS DEEMED CORRECT. THE ANTI-TPO REAGENT LOT NUMBER WAS 62835101 WITH AN EXPIRATION DATE OF 30-APR-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15731252 ↗
• MalfunctionAug 23, 2021False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ROCHE DIAGNOSTICS ELECSYS ANTI-TG AND ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO ON A COBAS 6000 E 601 MODULE. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO A CLINICIAN WHO QUESTIONED THE VALUES. THIS MEDWATCH WILL APPLY TO THE ANTI-TPO ASSAY. PLEASE REFER TO THE MEDWATCH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TG ASSAY. THE SAMPLE WAS TESTED TWICE ON THE E 601 ANALYZER, RESULTING IN ANTI-TG VALUES OF 27.13 IU/ML AND 27.09 IU/ML (REFERENCE RANGE = < 115 IU/ML). THE SAMPLE WAS REPEATED ON AN ALINITY ANALYZER ON (B)(6) 2021, RESULTING IN AN ANTI-TG VALUE OF 195.05 IU/ML (REFERENCE RANGE = < 4.11 IU/ML). THE SAMPLE WAS TESTED TWICE ON THE E 601 ANALYZER, RESULTING IN ANTI-TPO VALUES OF 28.00 IU/ML AND 27.28 IU/ML (REFERENCE RANGE = < 34 IU/ML). THE SAMPLE WAS REPEATED ON AN ALINITY ANALYZER ON (B)(6) 2021, RESULTING IN AN ANTI-TPO VALUE OF 27.90 IU/ML (REFERENCE RANGE = < 5.6 IU/ML). THE SERIAL NUMBER OF THE E 601 ANALYZER IS 2717-16.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355474 ↗
• MalfunctionAug 21, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT FROM A COBAS 6000 E 601 MODULE. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT HAS DWARFISM AND HAD BEEN INJECTED WITH RECOMBINANT HUMAN GROWTH HORMONE BEGINNING IN (B)(6) 2017. AN INTERFERENCE WAS SUSPECTED AS THE RESULTS PORTRAY HYPERTHYROIDISM HOWEVER THE PATIENT HAD NO THYROID SYMPTOMS AND APPEARED NORMAL. THE RESULTS OF THE PATIENT'S THYROID FUNCTION TESTS WERE NORMAL ON (B)(6) 2018. HOWEVER, WITH SAMPLE FROM (B)(6) 2018, THE ELECSYS FT3 III AND ELECSYS FT4 II ASSAY CONCENTRATIONS WERE BOTH INCREASED. THE SAMPLES WERE TESTED WITH THE BECKMAN, SIEMENS, AND ABBOTT METHODS AND THE RESULTS WERE DISCREPANT FOR FT3, FT4, ELECSYS TSH ASSAY, AND ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO. THIS MEDWATCH IS FOR THE ANTI-TPO ASSAY. REFER TO THE MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS FOR THE OTHER ASSAYS INVOLVED: (B)(6). NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800833 ↗
• MalfunctionJul 20, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT4 II (FT4 II), TSH, ANTI-TPO AND ANTI-TSHR ON A COBAS E 801 MODULE. REFER TO THE ASSOCIATED MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). BETWEEN (B)(6) 2017 AND (B)(6) 2018 THE PATIENT HAD INCREASED FT4 II RESULTS (29-52 PMOL/L) AND LOW TSH RESULTS (0.04 - 0.17 MIE/L) IN 14 DIFFERENT SAMPLES FROM THE PATIENT WHEN TESTED ON THE E801 MODULE. ANTI-TPO RESULTS WERE > 600 IE/ML IN 6 DIFFERENT SAMPLES FROM THE PATIENT WHEN TESTED ON THE E801 MODULE. THE PATIENT PREVIOUSLY HAD NEGATIVE ANTI-TSHR RESULTS IN 2 DIFFERENT SAMPLES WHEN TESTED BY THE BRAHMS METHOD, HOWEVER, WHEN THE CUSTOMER CHANGED TO THE ROCHE METHOD IN (B)(6) 2017, THE PATIENT HAD POSITIVE ANTI-TSHR IN 7 DIFFERENT SAMPLES WHEN TESTED ON THE E801 MODULE. THE ACTUAL RESULTS WERE NOT PROVIDED. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PATIENT WAS DIAGNOSED WITH HYPERTHYROIDISM AND TREATMENT WAS STARTED WITH NEO-MERCAZOLE IN (B)(6) 2017. THE CUSTOMER SUSPECTS AN INTERFERENCE IN THE PATIENT SAMPLE AS THE PATIENT'S CLINICAL SYMPTOMS DO NOT AGREE WITH THE RESULTS. THE CUSTOMER SENT 3 PATIENT SAMPLES OBTAINED IN (B)(6) 2018 AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7706291 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051890. One submission often covers many models, so check the product and lot details in each record.

• Z-2981-2020 · Aug 20, 2020 · Terminated
  Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190