Elecsys TSH 08443432214Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613336193693), received between Nov 29, 2023 and Jan 30, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2025False Positive Result; False Positive Result

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF NON-REPRODUCIBLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275038 ↗
• MalfunctionOct 21, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT TESTED FOR ELECSYS TSH ON A COBAS 8000 E 801 MODULE AND 1 PATIENT TESTED ON A COBAS 8000 E 602 MODULE. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501221 ↗
• MalfunctionApr 26, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TSH ELECSYS E2G 300 V2 (TSH) AND ELECSYS FT3 (FT3) ON A COBAS 8000 E 801 MODULE COMPARED TO THE ABBOTT METHOD. THIS MEDWATCH WILL COVER TSH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 RESULTS. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192688 ↗
• MalfunctionMar 7, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TSH ELECSYS E2G 300 V2 AND ELECSYS FT3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 CORE UNIT. PLEASE REFER TO THE HIGHLIGHTED SECTION OF ATTACHMENT (B)(6) FOR PATIENT RESULTS. THE CUSTOMER ALSO PERFORMED A TSH DILUTION TEST ON THE SAMPLE. A DILUTION OF (X2) PRODUCED A CONVERSION RESULT OF 3.080 IU/ML AND A RECOVERY RESULT OF 134%. A DILUTION OF (X5) PRODUCED A CONVERSION RESULT OF 3.920 IU/ML AND A RECOVERY RESULT OF 170%. A DILUTION OF (X10) PRODUCED A CONVERSION RESULT OF 4.440 IU/ML AND A RECOVERY RESULT OF 193%. THIS MEDWATCH WILL APPLY TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857013 ↗
• MalfunctionFeb 28, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH V2 (TSH V2), ELECSYS FT4 III AND ELECSYS FT4 IV RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 8000 CORE UNIT AND THE INVESTIGATION LABORATORY'S COBAS E 801 MODULE. THE REPORTER STATED THAT THEY SUSPECT SOME NON-SPECIFIC INTERFERENCE IN ELECSYS THYROID ASSAYS. THE PATIENT SAMPLE WAS RERUN ON WAKO ACCURASEED AND ABBOTT ALINITY ANALYZERS. IT WAS ALSO SENT TO AN INVESTIGATION LABORATORY THAT USES A COBAS E 801 MODULE. THIS MDR IS FOR THE TSH V2 ASSAY. PLEASE REFER TO: MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 IV ASSAY. MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796434 ↗
• MalfunctionFeb 14, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TSH ELECSYS E2G 300 V2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE. REFER TO THE HIGHLIGHTED RESULTS IN THE ATTACHMENT (B)(4) FOR PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705840 ↗
• MalfunctionDec 22, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH V2 (TSH V2) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT AND THE INVESTIGATION LABORATORY'S COBAS E 801 MODULE. THE REPORTER STATED THAT THEY PERFORMED A POLYETHYLENE GLYCOL (PEG) ADDITION TEST BUT THE RECOVERY RATE WAS LOW PROMPTING THEM TO SEND THE PATIENT SAMPLE TO AN INVESTIGATION LABORATORY. THE INVESTIGATION LABORATORY ALSO SENT THE PATIENT SAMPLE TO AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT. 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 18384338 ↗
• MalfunctionDec 19, 2023Cross Reactivity; High Test Results; Cross Reactivity; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TSH RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2023, THE RESULT FROM AN ABBOTT I2000SR WAS 1.0957 UIU/ML. ON (B)(6) 2023, THE RESULT FROM THE COBAS E801 WAS 33.4 UIU/ML. ON (B)(6) 2023, THE RESULT FROM A SIEMENS CENTAUR XP WAS 1.441 UIU/ML. THE SAMPLE WAS DILUTED SAMPLE USING SALINE AND LOW TSH SERUM AND THE RESULTS WERE 1.524 AND 1.46 UIU/ML. ON (B)(6) 2023, THE RESULT FROM THE COABS E801 WAS 33.4 UIU/ML. THE SAMPLE FROM (B)(6) 2023 WAS DILUTED USING LOW TSH SERUM AND THE RESULTS WERE: UNDILUTED: 35 UIU/ML. 1:1 DILUTION: 35.1 UIU/ML. 1:2 DILUTION: 60.2 UIU/ML. 1:4 DILUTION: 89.6 UIU/ML. 1:8 DILUTION: 117.6 UIU/ML. THE RESULT USING 25% PEG 1:1 WAS 1.54 UIU/ML. RECOVERY 8.8%. THE SAMPLE FROM (B)(6) 2023 WAS DILUTED USING LOW TSH SERUM AND THE RESULTS WERE: UNDILUTED: 34.3 UIU/ML. 1:1 DILUTION: 33.5 UIU/ML. 1:2 DILUTION: 56.2 UIU/ML. 1:4 DILUTION: 82 UIU/ML. 1:8 DILUTION: 116.8 UIU/ML. THE RESULT USING 25% PEG 1:1 WAS 1.32 UIU/ML. RECOVERY 7.7%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358814 ↗
• MalfunctionNov 29, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY, AND TSH V2 (TSH V2) ASSAY ON A COBAS 8000 E801 MODULE. THE SAMPLES ALSO HAD DISCREPANT RESULTS WHEN TESTED ON ANOTHER COBAS 8000 E801 MODULE AND ON A COBAS E411 IMMUNOASSAY ANALYZER. THIS MEDWATCH WILL APPLY TO THE TSH V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 III V2 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENTS' DATA. THE SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER. THE SAMPLES WERE PROVIDED FOR INVESTIGATION WHERE THEY TESTED ON A 2ND E801 ANALYZER AND ON E411 ANALYZER. THE SAMPLES WERE ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230631 ↗