Elecsys T4 07027885190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04015630939800), received between Jul 19, 2018 and May 19, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Improper Chemical Reaction; Incorrect, Inadequate or Imprecise Result or Readings; Improper Chemical Reaction

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T4 ASSAY FROM ONE PATIENT SAMPLE TESTED ON TWO COBAS E 801 ANALYTICAL UNITS WITH SERIAL NUMBERS (B)(6). THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE REPORTER BELIEVES THAT THE ELECSYS T4 ASSAY HAS INTERFERENCE AND THAT A T4 RESULT STRONGLY ABOVE THE REFERENCE RANGE WITH NORMAL TSH, FT3, FT4, AND T3 RESULTS IS IMPOSSIBLE CLINICALLY. THE PATIENT SAMPLE WAS RERUN ON THEIR OTHER E 801 MODULE AND A BECKMAN ANALYZER. THE REPORTER BELIEVES THAT THE RESULT FROM THE BECKMAN ANALYZER IS MORE RELIABLE. PLEASE REFER TO THE ATTACHMENT PT-81683 IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16966947 ↗
• MalfunctionMar 31, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE AND A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6).FOR INFORMATION ON THE FT3 III RESULTS. THE T4 RESULT ON THE E601 ANALYZER WAS >320 NMOL/L. THE SAMPLE WAS TESTED ON ANOTHER LABORATORY'S E801 ANALYZER AND THE RESULT WAS 186 NMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E601 ANALYZER SERIAL NUMBER (B)(4). THE OTHER LABORATORY'S E801 ANALYZER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16658616 ↗
• MalfunctionAug 5, 2022High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT TESTED ON A COBAS E801 MODULE COMPARED TO THE BECKMAN, ABBOTT, SIEMENS AND WANTAI METHODS. DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS T3 (T3), ELECSYS FT3 (FT3), ELECSYS T4 (T4), ELECSYS FT4 (FT4) AND ELECSYS TSH (TSH). THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE DOCTOR AS THE PATIENT HAD BEEN TAKING METHIMAZOLE. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178036 ↗
• MalfunctionMay 3, 2022High Test Results; Low Test Results; High Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS E801 MODULE. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED. THE SAMPLE WAS REPEATED ON THE E801 MODULE AND THE RESULTS WERE QUESTIONED AS THEY DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION. THE SAMPLE WAS REPEATED ON AN E801 MODULE AT A DIFFERENT HOSPITAL, A SIEMENS CENTAUR ANALYZER, A BECKMAN AU ANALYZER AND A MANDARY CL6000 ANALYZER WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS T4 (T4), T3, FT3 AND FT4. THE RESULTS FROM THE SIEMENS METHOD WERE BELIEVED TO BE CORRECT. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 RESULTS. THE COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(4). NEITHER THE CUSTOMER¿S E801 MODULE SERIAL NUMBER OR THE SERIAL NUMBER FOR THE OTHER HOSPITAL¿S E801 MODULE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14268935 ↗
• MalfunctionDec 2, 2021High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T3 (T3), ELECSYS T4 ASSAY (T4), ROCHE ELECSYS ANTI-TG (ANTI-TG) AND ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO (ANTI-TPO) ON 2 COBAS E801 MODULES AND A COBAS 6000 E 601 MODULE COMPARED TO AN IMMUSYSTEM ANALYZER AND AN ABBOTT ANALYZER. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TG RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TPO RESULTS. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER¿S E801 MODULE SERIAL NUMBER WAS (B)(4). THE SERIAL NUMBERS FOR THE E601 MODULE AND THE E801 MODULE USED AT THE DIFFERENT LABORATORIES WERE NOT PROVIDED. THE REAGENT LOT NUMBERS USED WITH THE E601 MODULE AND THE E801 MODULE USED AT THE OTHER LABORATORIES WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917305 ↗
• MalfunctionJan 29, 2020High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. QUESTIONABLE HIGH ELECSYS T4 ASSAY RESULTS WERE GENERATED BY A COBAS 6000 E601 MODULE. THE EVENT INVOLVED ONE PATIENT SAMPLE. THE PATIENT'S AGE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT IS MALE. THE PATIENT'S RACE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9641140 ↗
• 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 T4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION RELATED TO THE TSH ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION RELATED TO THE FT4 ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION RELATED TO THE FT3 ASSAY, REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4)FOR INFORMATION RELATED TO THE T3 ASSAY, AND REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION RELATED TO THE ANTI-TSHR ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. VALUES HIGHLIGHTED IN YELLOW ARE DISCREPANT. 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 SA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384224 ↗
• 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 T4 ASSAY. PLEASE REFER TO THE FOLLOWING MEDWATCHES WITH THE FOLLOWING 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 8059180 ↗
• 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 T4 ASSAY. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T3 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. 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 8023317 ↗
• MalfunctionOct 30, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS T4 ASSAY ON A COBAS 8000 E 801 MODULE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS TESTED THREE TIMES ON THE CUSTOMER'S E 801 ANALYZER, RESULTING WITH T4 VALUES OF 24.4 UG/DL, 24.9 UG/DL ACCOMPANIED BY A DATA FLAG, AND 21.6 UG/DL. THE SAMPLE WAS TESTED AT ANOTHER LABORATORY ON A COBAS 6000 E 601 MODULE, RESULTING WITH A T4 VALUE OF 12.21 UG/DL. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER IS (B)(4). THE SERIAL NUMBER OF THE E 601 ANALYZER USED AT THE OTHER LABORATORY WAS ASKED FOR, BUT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8018332 ↗
• 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 7702332 ↗