Elecsys FT3 III 6437206160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630934171), received between Jul 31, 2018 and Oct 29, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2021High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT4 III ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 602 MODULE. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. IT WAS REQUESTED BUT NOT PROVIDED IF THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. DUE TO THE TSH RESULT NOT MATCHING THE CLINICAL STATUS OF "GRAVES," THE CUSTOMER PERFORMED REPEAT TESTING WITH THE PATIENT'S SAMPLE ON THE COBAS 8000 E 602 MODULE, AN ABBOTT ARCHITECT, AND A BECKMAN COULTER ANALYZER. THIS MEDWATCH IS FOR FT3 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT4 ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720272 ↗
• MalfunctionOct 15, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT SAMPLE FROM COBAS 8000 COBAS E 602 MODULE SERIAL NUMBER (B)(4) WHEN COMPARED TO THE RESULTS FROM AN ABBOTT ARCHITECT. THE RESULTS FROM THE COBAS E602 DID NOT CORRELATE WITH PATIENT SYMPTOM AND AN INTERFERENCE WAS SUSPECTED. THIS MEDWATCH IS FOR ELECSYS FT3. REFER TO THE FOLLOWING MEDWATCH WITH PATIENT IDENTIFIER FOR THE OTHER ASSAYS INVOLVED: ELECSYS TSH ASSAY=(B)(6). ELECSYS T3 ASSAY=(B)(6). ELECSYS T4 ASSAY=(B)(6). ELECSYS FT4 ASSAY=(B)(6). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7965348 ↗
• MalfunctionJul 31, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE HIGH ELECSYS FT4 II ASSAY AND ELECSYS FT3 III RESULTS FOR ONE PATIENT SAMPLE FROM COBAS 6000 E601 MODULE SERIAL NUMBER (B)(4). THIS MEDWATCH IS FOR FT3. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT4 ASSAY. THE INITIAL FT4 RESULT WAS 30.08 PMOL/L AND INITIAL FT3 RESULT WAS 6.94 PMOL/L. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED ON AN ABBOTT ANALYZER. THE FT4 RESULT WAS 19.6 PMOL/L AND THE FT3 RESULT WAS 5.67 PMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736197 ↗