Elecsys Anti-Tg 07026919190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04015630939619), received between Nov 7, 2021 and Oct 12, 2023 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO AND ROCHE DIAGNOSTICS ELECSYS ANTI-TG RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MDR IS FOR THE ANTI-TG ASSAY. PLEASE REFER TO MDR WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TPO ASSAY. THE REPORTER STATED THAT THE DIFFERENCES BETWEEN THE ANTI-TG AND ANTI-TPO RESULTS FROM THE ANALYZER AND THE MINDRAY INSTRUMENT WERE TOO LARGE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY BECAUSE THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE INITIAL ANTI-TG RESULT FROM THE ANALYZER WAS 432.9 IU/ML. THE REPEAT RESULT FROM THE MINDRAY INSTRUMENT WAS 6.61 IU/ML. THE REFERENCE RANGES WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919240 ↗
• MalfunctionOct 11, 2023High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ANTI-TG ELECSYS E2G RESULT FROM THE COBAS E 801 MODULE. THE RESULT FROM THE COBAS E 801 MODULE WAS REPORTEDLY 398 IU/ML. ON 01-SEP-2023, USING THE BECKMAN COULTER ACCESS DXL METHOD, THE RESULT WAS REPORTEDLY 3.4 IU/ML. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE PHYSICIAN QUESTIONED HOW TO COMPARE THE TWO RESULTS AND HOW TO INTERPRET THEM. IT IS NOT KNOWN WHICH RESULT WAS BELIEVED TO BE CORRECT. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON A LATER UNKNOWN DATE AND THE ANTI-TG RESULT ON THE COBAS E 801 MODULE WAS REPORTEDLY THE SAME. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912373 ↗
• MalfunctionJan 12, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TG AND ELECSYS ANTI-TPO RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THIS MEDWATCH IS FOR THE ANTI-TG ASSAY. PLEASE REFER TO MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TPO ASSAY. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS WERE COMPARED TO THREE OTHER NON-ROCHE ANALYZERS. THE REPORTER COMPLAINED THAT THE RESULTS FROM THE THREE NON-ROCHE ANALYZERS WERE ALL IN ACCORDANCE AND ONLY THE RESULTS FROM THE REPORTED ANALYZER WERE LOW. PLEASE REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16149897 ↗
• 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 ANTI-TG ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED 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-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 15726132 ↗
• MalfunctionJun 29, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TG RESULTS FOR ONE PATIENT TESTED ON TWO COBAS 8000 E 801 MODULES. THE PATIENT'S INITIAL ELECSYS ANTI-TG RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME E 801 MODULE, AN EXTERNAL LABORATORY'S E 801 MODULE, AN ABBOTT ANALYZER, AND A SIEMENS ANALYZER. THE PATIENT'S ELECSYS ANTI-TG RESULT ON THE E 801 MODULE SERIAL NUMBER (B)(4) WAS 24.6 IU/ML. THE PATIENT'S REPEAT ELECSYS ANTI-TG RESULT ON THE SAME E 801 MODULE WAS 13.0 IU/ML. THE ANTI-TG REAGENT LOT NUMBER WAS 59537501 WITH AN EXPIRATION DATE OF 28-FEB-2023. AT AN EXTERNAL LABORATORY, THE PATIENT'S ANTI-TG RESULT ON AN E 801 MODULE WAS 25.0 IU/ML. THE E 801 MODULE SERIAL NUMBER, ANTI-TG REAGENT LOT NUMBER, AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE PATIENT'S ANTI-TG RESULTS WERE GREATER THAN THE EXPECTED HIGH LIMIT ON THE ABBOTT ANALYZER AND THE SIEMENS ANALYZER. THE PATIENT'S CLINICIAN DID NOT FIND ELECSYS RESULTS WERE COMPATIBLE WITH THE PATIENT'S FINDINGS, BUT THE ABBOTT AND SIEMENS RESULTS WERE ACCEPTABLE. THIS MEDWATCH IS FOR ANTI-TG. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE E 801 MODULES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853495 ↗
• MalfunctionJun 17, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH MULTIPLE THYROID ASSAYS ON A COBAS 8000 E 801 MODULE. ALL COMPLAINED THYROID RESULTS WERE ELEVATED WHEN MEASURED WITH THE ROCHE ASSAYS. THE SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. RESULTS FROM THE FOLLOWING ASSAYS ARE AFFECTED: FT3, THE ELECSYS FT4 III ASSAY, ANTI-TPO, ANTI-TG, AND ANTI-TSHR. THE SPECIFIC FT3, ANTI-TPO, ANTI-TG, AND ANTI-TSHR REAGENTS USED WERE REQUESTED, BUT NOT PROVIDED. THIS MEDWATCH WILL APPLY TO THE ANTI-TG 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 FT4 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TPO ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TSHR ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE FIRST SAMPLE WAS TESTED ON (B)(6) 2022 AND HAD ELEVATED THYROID TEST RESULTS WHEN TESTED ON THE E 801 ANALYZER. WHEN TESTED AT ANOTHER SITE USING UNKNOWN METHODS, THE VALUES WERE "NORMAL". THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734806 ↗
• MalfunctionMar 12, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TPO RESULTS FOR 2 PATIENTS AND QUESTIONABLE ELECSYS ANTI-TG RESULTS FOR 1 PATIENT TESTED WITH A COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4) COMPARED TO A COBAS E 602 SERIAL NUMBER (B)(4). (B)(6). THIS RESULT WAS RELEASED TO MEDICAL PERSONNEL. THIS MEDWATCH IS FOR THE ANTI-TG ASSAY. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TPO ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742238 ↗
• MalfunctionMar 4, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III, ELECSYS FT4 III ASSAY, ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO, ROCHE DIAGNOSTICS ELECSYS ANTI-TG, AND ELECSYS ANTI-TSHR RESULTS FOR ONE PATIENT TESTED ON TWO COBAS 8000 E 801 MODULES. THE SERIAL NUMBERS FOR THE E 801 MODULES WERE (B)(4). THE PATIENT'S ELECSYS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S PHYSICIAN QUESTIONED THE REPORTED RESULTS AS THE RESULTS DID NOT FIT THE PATIENT'S CLINICAL PICTURE. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO A DIFFERENT LABORATORY AND THE SAMPLE WAS TESTED ON AN UNKNOWN ROCHE ANALYZER "AND HAD SIMILAR RESULTS." THE PATIENT'S SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON A "PRESUMABLY" SIEMENS ANALYZER. THE CUSTOMER CONFIRMED THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGES, BUT ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THIS MEDWATCH IS FOR THE ANTI-TG ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT4 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT3 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TPO ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TSHR ASSA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13671492 ↗
• 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 ANTI-TG. REFER TO MEDWATCH WITH PATIENT (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH PATIENT (B)(6) FOR INFORMATION ON THE T4 RESULTS AND MEDWATCH WITH PATIENT (B)(6) FOR INFORMATION ON THE ANTI-TPO 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 12917373 ↗
• MalfunctionNov 15, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE ELECSYS ANTI-TG RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE. THE E 801 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE PATIENT'S INITIAL ELECSYS ANTI-TG RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PROVIDED THE PATIENT'S SAMPLE FOR FURTHER INVESTIGATION AND THE SAMPLE WAS TESTED ON A COBAS 8000 E 801 MODULE AND AN ABBOTT ARCHITECT. REFER TO THE ATTACHMENT ON THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12810450 ↗
• MalfunctionNov 7, 2021High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ANTI-TG ASSAY ON A COBAS 8000 E 801 MODULE USED FOR INVESTIGATION. THE SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. DATA FROM OTHER SAMPLES COLLECTED FROM THE SAME PATIENT HAVE BEEN PREVIOUSLY REPORTED IN MFG REPORT NUMBERS 1823260-2020-01065 AND 1823260-2020-01066. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON THE E 801 ANALYZER, RESULTING IN A VALUE OF 30.3 IU/ML (REFERENCE RANGE = < 30 IU/ML). THE SAMPLE WAS REPEATED ON AN ABBOTT ARCHITECT ANALYZER, RESULTING IN A VALUE OF 2.04 IU/ML (REFERENCE RANGE = < 4.11 IU/ML). THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758225 ↗