Elecsys T3 11731360122Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630899937), received between Aug 16, 2018 and Jul 28, 2020 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2020High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. QUESTIONABLE HIGH RESULTS WERE GENERATED BY THE ELECSYS T3 ASSAY ON A COBAS 8000 E 602 MODULE. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: QUESTIONABLE T3 RESULTS THE PATIENT WAS "APPROXIMATELY (B)(6) YEARS".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10332035 ↗
• MalfunctionJan 28, 2020High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. QUESTIONABLE HIGH ELECSYS T3 RESULTS WERE GENERATED BY A COBAS 6000 E601 MODULE. THE EVENT INVOLVED ONE PATIENT SAMPLE. THE PATIENT'S AGE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT IS MALE. THE PATIENT'S RACE WAS REQUESTED, BUT NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9638531 ↗
• 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. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH IS FOR ELECSYS T3 ASSAY. REFER TO THE FOLLOWING MEDWATCH WITH PATIENT IDENTIFIER FOR THE OTHER ASSAYS INVOLVED: ELECSYS TSH ASSAY= (B)(6) ; ELECSYS T4 ASSAY= (B)(6); ELECSYS FT3= (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 7965336 ↗
• MalfunctionAug 16, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE THYROID RESULTS FOR 1 PATIENT TESTED ON A COBAS 6000 E 601 MODULE COMPARED TO COMPETITOR (ABBOTT AND RIA) RESULTS. THE CUSTOMER STATED THAT THE PATIENT'S ELECSYS T3 AND ELECSYS T4 ASSAY RESULTS WERE SIMILAR BEFORE AND AFTER T3/T4 SUPPLEMENTATION AND THEY DID NOT CONSIDER THAT REASONABLE. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR T3, T4, ELECSYS FT4 II ASSAY, AND ELECSYS TSH ASSAY. THE SPECIFIC DATE OF TESTING FOR THE DATA THAT IS A REPORTABLE MALFUNCTION IS NOT KNOWN, BUT CLARIFICATION HAS BEEN REQUESTED. THIS MEDWATCH WILL COVER THE T3 DATA. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T4 RESULTS. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 II RESULTS. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. THE CUSTOMER DID NOT PROVIDE THE THYROID DATA FOR THE TIME PERIOD BEFORE THE PATIENT WAS TAKING T3/T4 SUPPLEMENTS. THE CUSTOMER PERFORMED MULTIPLE DILUTIONS OF DIFFERENT DILUTION FACTORS USING TWO DIFFERENT DILUENTS, BUT PRODUCT LABELING DOES NOT SUPPORT DILUTION TESTING. THE ERRONEOUS RESULTS WERE NOT RELEASED OUTSIDE OF THE LA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790436 ↗