Elecsys T3 07027869190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04015630939794), received between Jul 19, 2018 and Nov 4, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 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, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T4 (T4), ELECSYS FT3 III VER.2, AND ELECSYS T3 (T3) ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS T3 (T3) ASSAY. PLEASE REFER TO THE MEDWATCH WITH: A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS T4 (T4) ASSAY. A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS FT3 III VER.2 ASSAY. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20603346 ↗
• MalfunctionNov 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE THYROID ASSAY RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT TESTED ON A COBAS 8000 E 801 MODULE. RESULTS FROM THE FOLLOWING ASSAYS WERE AFFECTED: ELECSYS T3, THE ELECSYS T4 ASSAY, ELECSYS FT3 III, THE ELECSYS FT4 ASSAY, ROCHE DIAGNOSTICS ELECSYS ANTI-TG, AND ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO. THE THYROID RESULTS WERE NOT CONSISTENT WITH THE PATIENT'S CLINICAL SITUATION. ALL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR AND PATIENT. THIS MEDWATCH WILL APPLY TO THE T3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TG ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TPO ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE FROM (B)(6) 2022 WAS REPEATED ON (B)(6) 2022. AN EXPERIMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727197 ↗
• MalfunctionAug 15, 2022High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T3 (T3), ELECSYS FT3 III (FT3 III) AND ELECSYS T4 (T4) ON A COBAS 8000 CORE UNIT COMPARED TO THE SIEMENS METHOD. THIS MEDWATCH WILL COVER T3. 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 T4 RESULTS. THE T3 RESULT FROM THE ROCHE METHOD WAS 3.56 NG/ML. THE RESULT FROM THE SIEMENS METHOD WAS 1.13 NG/ML. THE FT3 III RESULT FROM THE ROCHE METHOD WAS 7.26 PG/ML. THE RESULT FROM THE SIEMENS METHOD WAS 3.22 PG/ML. THE T4 RESULT FROM THE ROCHE METHOD WAS 24.9 UG/DL. THE RESULT FROM THE SIEMENS METHOD WAS 7.78 UG/DL. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION. THE SIEMENS RESULTS WERE BELIEVED TO BE "NORMAL." THE COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224962 ↗
• MalfunctionOct 7, 2021High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T3 RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE PATIENT'S ELECSYS T3 RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE PATIENT'S SAMPLE ON THE COBAS 8000 E 801 MODULE AS WELL ON A SIEMENS ADVIA CENTAUR ANALYZER. THE DATE OF TESTING WITH THE SIEMENS ADVIA CENTAUR ANALYZER WAS REQUESTED BUT NOT PROVIDED. ON (B)(6) 2021, THE PATIENT'S ELECSYS T3 RESULT WAS 651 NG/DL WITH A DATA FLAG. THE PATIENT'S T3 RESULT ON THE SIEMENS ADVIA CENTAUR ANALYZER WAS 87 NG/DL. ON (B)(6) 2021, THE PATIENT'S REPEAT ELECSYS T3 RESULT WAS 651 NG/DL WITH A DATA FLAG. THE CUSTOMER DETERMINED THE RESULT OF 87 NG/DL WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12589188 ↗
• MalfunctionNov 27, 2019High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY, THE ELECSYS FT4 III ASSAY, ELECSYS FT3 III, THE ELECSYS T4 ASSAY, ELECSYS T3, AND THE ELECSYS ANTI-TSHR IMMUNOASSAY ON A COBAS 8000 E 801 MODULE AND A SECOND E 801 MODULE USED FOR INVESTIGATION. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE T3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T4 ASSAY, AND REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TSHR ASSAY. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER ON (B)(6) 2019. THE SAMPLE WAS REPEATED USING THE ARCHITECT METHOD (FOR TSH, FT4, FT3, T4, T3) AND YAMASA METHOD (FOR ANTI-TSHR). THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER ON (B)(

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384223 ↗
• MalfunctionNov 12, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR MULTIPLE TESTS FOR 1 PATIENT TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO AN ADVIA CENTAURO. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR ELECSYS FT3 III, ELECSYS PROLACTIN ASSAY, ELECSYS T3, ELECSYS T4 ASSAY, ELECSYS TESTOSTERONE II ASSAY, AND ELECSYS ESTRADIOL III ASSAY. THE CUSTOMER SUSPECT THERE IS AN INTERFERENCE AFFECTING THE PATIENT SAMPLE. THIS MEDWATCH WILL COVER THE T3 ASSAY. PATIENT IDENTIFIERS FOR INFORMATION RELATED TO EACH OTHER AFFECTED ASSAY: (B)(6). THE DISCREPANT RESULTS ARE HIGHLIGHTED. IT WAS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059178 ↗
• MalfunctionOct 31, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS T3 ON A COBAS 8000 E 801 MODULE. THE SECOND SAMPLE ALSO HAD AN ERRONEOUS RESULT FOR THE ELECSYS T4 ASSAY WHEN TESTED ON THE SAME E 801 ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE T3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T4 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE ERRONEOUS RESULTS ARE HIGHLIGHTED IN RED. THE CORRECT RESULTS WHICH WERE REPORTED OUTSIDE OF THE LABORATORY ARE HIGHLIGHTED IN YELLOW. ALL ERRONEOUS RESULTS WERE GENERATED ON THE E 801 ANALYZER. THE SAMPLES WERE REPEATED ON 4 DIFFERENT ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZERS. SAMPLE 2 IS FROM A (B)(6) YEAR OLD FEMALE PATIENT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8023088 ↗
• MalfunctionOct 26, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS T3 RESULT FOR THREE PATIENT SAMPLES FROM COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, ONLY THE RESULTS FOR TWO OF THE SAMPLES WERE DISCREPANT. PATIENT 1 INITIAL RESULTS WERE 456 AND 466 NG/DL. THE REPEAT RESULTS FROM ANOTHER COBAS 8000 E 801 MODULE WERE 390 AND 387 NG/DL. THE REPEAT RESULT FROM A ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER WAS 168 NG/DL. THE REPEAT RESULT FROM A COBAS 8000 E 602 MODULE WAS 169 NG/DL. ON (B)(6) 2018, PATIENT 2 INITIAL RESULT WAS 425 NG/DL. THE SAMPLE WAS REPEATED ON A COBAS 6000 E 601 MODULE AND THE RESULTS WERE 256.6 NG/DL AND 264.4 NG/DL. THIS RESULT WAS CONSIDERED CORRECT AND RELEASED TO THE PATIENT. THE SAMPLE WAS REPEATED ON THE 8000 E 801 MODULE AND THE RESULT WAS 382 NG/DL. THIS PATIENT WAS A (B)(6) FEMALE. 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 8008927 ↗
• MalfunctionAug 30, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS T3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E 801 MODULE AND A COBAS 6000 E 601 MODULE. OF THE DATA PROVIDED, THERE WERE DISCREPANT T3 AND ELECSYS FT4 II ASSAY RESULTS. THE E 801 SERIAL NUMBER IS (B)(4) THE E 601 SERIAL NUMBER IS (B)(4). THIS MEDWATCH WILL COVER THE T3 DATA. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 II RESULTS. THE INITIAL T3 RESULT WAS 422 NG/DL ON THE E 801. THE PHYSICIAN REQUESTED A REPEAT FOR THE T3 RESULT. THE REPEAT T3 RESULT WAS 423 NG/DL ON THE E 801. THE SAMPLE WAS REPEATED ON AN E 601 AND THE T3 RESULT WAS 166.6 NG/DL. THE INITIAL FT4 II RESULT WAS 0.915 NG/DL ON THE E 801. AFTER THE PHYSICIAN REQUESTED THE REPEAT OF THE SAMPLE THE FT4 RESULT WAS 0.919 NG/DL ON THE E801. THE SAMPLE WAS REPEATED ON AN E 601 AND THE FT4 II RESULT WAS 1.43 NG/DL. 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 7834066 ↗
• MalfunctionJul 19, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE THYROID RESULTS FOR 2 PATIENT SAMPLES TESTED ON A COBAS 8000 E 801 MODULE AND A COBAS 8000 E 601 COMPARED TO A SIEMENS CENTAUR. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR ELECSYS TSH ASSAY (TSH), ELECSYS T3 (T3), ELECSYS T4 ASSAY (T4), AND ELECSYS FT4 II ASSAY (FT4 II). MEDWATCHES RELATED TO THIS ISSUE INCLUDED PATIENT IDENTIFIERS (B)(6). THE ERRONEOUS RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 SERIAL NUMBER WAS (B)(4). THE COBAS E601 SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702329 ↗