Elecsys T4 Assay 12017709122Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04015630912728), received between Aug 16, 2018 and Sep 26, 2023 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T4 (T4) AND ELECSYS FT4 (FT4) RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE T4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE FT4 ASSAY. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE REPORTER THEN SENT THE PATIENT SAMPLES TO ANOTHER LABORATORY THAT USES BECKMAN, ABBOTT, AND SIEMENS CENTAUR ANALYZERS. THE REPORTER STATED THAT THEY THINK THAT THE RESULTS FROM THE ABBOTT ANALYZER MATCHED THE PATIENT'S CLINICAL DIAGNOSIS. THE REPORTER WANTS TO KNOW IF THERE WAS AN INTERFERENCE WITH THE ROCHE ASSAYS. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816456 ↗
• MalfunctionSep 2, 2022High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T3 (T3), ELECSYS FT3 (FT3), ELECSYS T4 (T4), ELECSYS FT4 (FT4) AND ELECSYS TSH (TSH) ON A COBAS 8000 E 602 MODULE COMPARED TO THE SIEMENS AND AUTOBIO METHODS. THIS MEDWATCH WILL COVER T4. REFER TO 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, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED AS THEY DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL PICTURE. THE SAMPLE WAS REPEATED BY 2 OTHER METHODS. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS. THE E602 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349985 ↗
• MalfunctionJul 28, 2020High Test Results; High Test Results

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. QUESTIONABLE HIGH RESULTS WERE GENERATED FOR THE ELECSYS T4 ASSAY ON A COBAS 8000 E 602 MODULE. THE EVENT INVOLVED ONE PATIENT SAMPLE. THE PATIENTS' AGE WAS "APPROXIMATELY 50 YEARS". 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 10331934 ↗
• MalfunctionJul 26, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. DISCREPANT LOW RESULTS WERE GENERATED BY A COBAS 6000 E 602 MODULE. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: ONE SAMPLE WITH DISCREPANT RESULTS FOR THE ELECSYS T4 ASSAY. THE PATIENT'S AGE WAS (B)(6) YEARS. THE PATIENT'S GENDER WAS MALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830160 ↗
• MalfunctionMay 16, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS LOW RESULT WAS GENERATED BY THE COBAS 8000 E 602 MODULE. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: A LOW T4 RESULT NOT MATCHING THE PATIENT'S CLINICAL PICTURE. THE PATIENT'S AGE WAS (B)(6) YEARS OLD. THE PATIENT'S GENDER WAS MALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615535 ↗
• MalfunctionJan 29, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS HIGH ELECSYS T4 ASSAY RESULTS WERE GENERATED. THE EVENTS INVOLVED 1 PATIENT. THE PATIENT'S AGE WAS (B)(6). THE PATIENT'S WEIGHT WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT WAS FEMALE. THE PATIENT'S RACE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED BUT WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8285294 ↗
• 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 T4 ASSAY. REFER TO THE FOLLOWING MEDWATCH WITH PATIENT IDENTIFIER FOR THE OTHER ASSAYS INVOLVED: ELECSYS TSH ASSAY=(B)(6). ELECSYS T3 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 7965362 ↗
• 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 T4 DATA. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 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 7790435 ↗