Elecsys FT4 II Assay 6437281160Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630934232), received between Sep 14, 2018 and Mar 14, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024High Test Results; High Test Results

  A CUSTOMER ALLEGED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE ELECSYS FT4 II ASSAY ON THE COBAS 8000 E 602 MODULE. SAMPLE 1 RESULTED IN A FT4 VALUE OF 2.15 NG/DL WHEN TESTED ON THE E 602 MODULE. THE RESULT WAS HIGHER THAN EXPECTED AND WAS REPEATED ON THE SAME E 602 MODULE, RESULTING IN A FT4 VALUE OF 1.17 NG/DL. SAMPLE 2 RESULTED IN A FT4 VALUE OF 2.45 NG/DL WHEN TESTED ON THE E 602 MODULE. THE RESULT WAS HIGHER THAN EXPECTED AND WAS REPEATED ON THE SAME E 602 MODULE, RESULTING IN A FT4 VALUE OF 1.52 NG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902016 ↗
• MalfunctionMay 15, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FT4 II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E 601 MODULE WITH SERIAL NUMBER (B)(6). THE REPORTER STATED THAT TWO PHYSICIANS REQUESTED THE SAME ASSAY FOR THE PATIENT. TWO SAMPLE TUBES WERE THEN COLLECTED FROM A SINGLE BLOOD DRAW. THE REPORTER STATED THAT THE PATIENT SAMPLES WERE RUN ALMOST AT THE SAME TIME. THE RESULT OF THE FIRST SAMPLE TUBE WAS 0.1 NG/DL. THE RESULT OF THE SECOND SAMPLE TUBE WAS 1.1 NG/DL. THIS RESULT WAS DEEMED CORRECT. THE RESULTS FROM BOTH SAMPLE TUBES WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16932077 ↗
• MalfunctionNov 16, 2021High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 II RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 E601 MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS REPORTED TO THE CLINICIAN, WHO ASKED THAT THE SAMPLE BE RERUN ON AN ABBOTT INSTRUMENT. THE PATIENT'S SAMPLE HAD AN INITIAL RESULT OF 2.24 NG/DL. ON (B)(6) 2021, THE REPEAT RESULT WAS 0.88 NG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821522 ↗
• MalfunctionJan 25, 2019Non Reproducible Results; Non Reproducible Results

  THIS REPORT SUMMARIZES <NOE>5</NOE> MALFUNCTION EVENTS. ERRONEOUS NON-REPRODUCIBLE RESULTS WERE GENERATED BY THE COBAS 8000 E 801 MODULE. THE EVENTS INVOLVED A TOTAL OF 6 PATIENTS WITH THE FOLLOWING: 1 ELECSYS CA 125 II ASSAY, 1 ELECSYS CA 19-9, 2 ELECSYS TSH ASSAY, 1 ELECSYS TSH ASSAY. THE PROVIDED PATIENTS' AGES RANGED FROM (B)(6) TO (B)(6) YEARS. THE OTHER PATIENTS' AGES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED BUT WERE NOT PROVIDED. THERE WERE 3 FEMALES AND 1 MALE. THE OTHER PATIENTS' GENDERS WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' RACE WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITY WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8278955 ↗
• MalfunctionSep 18, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY AND ELECSYS FT4 II ASSAY RESULTS FOR ONE PATIENT FROM COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4) AND FROM A COBAS 8000 E 801 MODULE COMPARED TO THE RESULT FROM AN ABBOTT ARCHITECT. THIS MEDWATCH IS FOR FT4. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE TSH ASSAY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY BUT THE PATIENT'S ENDOCRINOLOGIST DID NOT BELIEVE THE TSH RESULT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SERIAL NUMBER OF THE COBAS 8000 E 801 MODULE WAS REQUESTED BUT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886685 ↗
• MalfunctionSep 14, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY HAVE ONE PATIENT WITH A HISTORY OF SAMPLES CONTAINING A SUSPECTED INTERFERING SUBSTANCE WHEN TESTED WITH THE ELECSYS TSH ASSAY AND THE ELECSYS FT4 II ASSAY ON A COBAS 8000 E 602 MODULE. THE CUSTOMER STATES THAT THEY HAVE RULED OUT ALL KNOWN INTERFERING SUBSTANCES LISTED IN PRODUCT LABELING FOR BOTH ASSAYS. THE PATIENT ALSO DID NOT TAKE ANY BIOTIN SUPPLEMENTS. THE CUSTOMER PROVIDED DATA FOR ONE SAMPLE FROM THE PATIENT WITH ERRONEOUS TSH AND FT4 RESULTS WHEN COMPARING TO RESULTS MEASURED WITH COMPETITOR SYSTEMS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS FROM THE COMPETITOR SYSTEMS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY. THE SAMPLE RESULTED WITH A TSH VALUE OF 0.005 MIU/L WHEN TESTED ON THE E 602 ANALYZER. THE SAMPLE WAS REPEATED ON A BECKMAN DXI, RESULTING WITH A TSH VALUE OF 0.10 MIU/L (BECKMAN DXI TSH REFERENCE RANGE = 0.3 - 4.3 MIU/L FOR PATIENTS >/= TO 1 YEAR OF AGE). THE SAMPLE RESULTED WITH A FT4 VALUE OF 2.61 NG/DL WHEN TESTED ON THE E 602 ANALYZER. THE SAMPLE WAS REP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877666 ↗