Elecsys T4 09007741190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336171660), received between Feb 21, 2022 and Jan 26, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Non Reproducible Results

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FOR ONE PATIENT FROM THE COBAS E411 RACK ANALYZER. 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 24183967 ↗
• MalfunctionJul 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Low Readings

  1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION ABOUT QUESTIONABLE HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS 6000 E601 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 22587462 ↗
• MalfunctionJan 30, 2025Low Test Results; Chemical Problem; Low Test Results; Chemical Problem

  1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FOR 1 PATIENT FROM THE COBAS E411 DISK ANALYZER. 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 21275399 ↗
• MalfunctionDec 1, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS T4 ASSAY ON A COBAS 6000 E 601 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A T4 VALUE OF > 24.86 UG/DL WITH THE DATA FLAG. SINCE THE VALUE WAS HIGH, THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 6.72 UG/DL. THE T4 REAGENT LOT NUMBER WAS 57011300. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892687 ↗
• MalfunctionFeb 21, 2022Display or Visual Feedback Problem; Non Reproducible Results; Display or Visual Feedback Problem; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE T4 ELECSYS E2G 300 V2 RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS E411 RACK WITH SERIAL NUMBER: (B)(4) COMPARED TO A VIDAS ANALYZER. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT FROM THE E 411 AT 1:51 PM WAS 246.5 NMOL/L WITH A DATA FLAG. THE RESULT FROM THE VIDAS ANALYZER AT 2:00 PM WAS 130.96 NMOL/L. THE VIDAS RESULT WAS REPORTEDLY MORE CONSISTENT WITH THE TOTAL THYROID PROFILE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569155 ↗