Elecsys Anti-Tg 09005021190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336171479), received between Jun 14, 2024 and Dec 22, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY, ELECSYS FT3 III ASSAY, ELECSYS VITAMIN D TOTAL III ASSAY, ELECSYS SHBG ASSAY, ELECSYS TESTOSTERONE II ASSAY, ELECSYS CORTISOL II ASSAY, ELECSYS PROLACTIN II ASSAY, ELECSYS FSH ASSAY, AND ELECSYS ANTI-TG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE ANTI-TG ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE VITAMIN D TOTAL III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE SHBG ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TESTOSTERONE II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CORTISOL II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE PROLACTIN II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FSH ASSAY, AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866557 ↗
• MalfunctionNov 21, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS' SAMPLES TESTED WITH ELECSYS ANTI-TG ASSAY ON A COBAS E 801 ANALYTICAL UNIT, NOT CORRELATING WITH THE PATIENTS' CLINICAL STATUS. THE CUSTOMER ALLEGED THAT THE INITIAL RESULTS FOR THE THYROIDECTOMIZED PATIENTS WERE ESTIMATED TO BE 20 TO 29 IU/ML (WHICH WERE HIGHER THAN THE EXPECTED VALUES) AND THAT THEY DID NOT MATCH THE PATIENTS' PREVIOUS RESULTS OF <18 IU/ML. NO EXACT VALUES FOR THE INITIAL RESULTS WERE PROVIDED. DISCREPANT RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED: ON (B)(6) 2025: INITIAL RESULT: 21 IU/ML. ON (B)(6) 2025: REPEAT RESULT: 28 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621616 ↗
• MalfunctionFeb 4, 2025High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. OF THE DATA PROVIDED, THE RESULTS FOR FT3, T4, T3, ANTI-TG AND ANTI-TPO WERE DISCREPANT. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. THIS MEDWATCH WILL COVER ANTI-TG. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T4 RESULTS, 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 AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TPO RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307378 ↗
• MalfunctionSep 5, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TPO, ELECSYS ANTI-TG, ELECSYS ANTI-TSHR, AND ELECSYS TESTOSTERONE II RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH COVERS THE ALLEGED RESULTS FOR THE ELECSYS ANTI-TG ASSAY. PLEASE REFER TO MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TSHR ASSAY RESULTS, MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS TESTOSTERONE II ASSAY RESULTS, AND MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TPO ASSAY RESULTS. REFER TO THE HIGHLIGHTED SECTION OF ATTACHMENT (B)(6) FOR PATIENT RESULTS. THE SAMPLES WERE REPEATED DUE TO THE RESULTS NOT MATCHING THE CLINICAL STATUS OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146073 ↗
• MalfunctionJun 14, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TG (ANTI-TG) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A COMPETITOR'S ANALYZER (BECKMAN COULTER) AT A DIFFERENT FACILITY. INITIAL RESULT: 275 IU/ML AND WAS INTERPRETED AS POSITIVE. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. ON (B)(6) 2024 THE ORIGINAL SAMPLE WAS SENT OUT TO ANOTHER LABORATORY AND REPEATED. REPEAT RESULT: 2.5 IU/ML (TESTED ON BECKMAN COULTER AND WAS INTERPRETED AS NEGATIVE). THE REPEAT RESULT MATCHED THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543023 ↗