Elecsys FT4 II 07027397190Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04015630939725), received between Jul 12, 2018 and Apr 13, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR 14 PATIENT SAMPLES TESTED WITH ELECSYS FT4 II ON COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). ALL SAMPLES INITIALLY RESULTED IN FT4 VALUES OF > 7.77 NG/DL. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT FT4 RESULTS. THE SAMPLE INITIALLY RESULTED IN AN FT4 VALUE OF > 7.77 NG/DL WITH A DATA FLAG AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 0.90 NG/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732307 ↗
• MalfunctionApr 10, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 II ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL PLASMA TUBE FT4 RESULT WAS 0.77 NG/DL. THE REPEAT RESULT WAS 0.93 NG/DL. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT. THE ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707419 ↗
• MalfunctionApr 23, 2020High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>2</NOE> MALFUNCTION EVENTS. QUESTIONABLE HIGH ELECSYS FT4 II ASSAY RESULTS WERE GENERATED BY A COBAS 8000 E 801 MODULE AND A COBAS 6000 E 601 MODULE. THE EVENTS INVOLVED A TOTAL OF 2 PATIENTS. THE KNOWN PATIENT'S AGE WAS (B)(6). THE OTHER PATIENT'S AGE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED BUT WERE NOT PROVIDED. THE KNOWN PATIENT WAS MALE. THE OTHER PATIENT'S GENDER WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: Test Result

  MAUDE report 9990993 ↗
• MalfunctionApr 25, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>2</NOE> MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED FOR ELECSYS FT4 II ASSAY . THE EVENTS INVOLVED A TOTAL OF 2 PATIENTS THAT WERE TESTED ON THE FOLLOWING INSTRUMENTS: 1 PATIENT TESTED ON A COBAS E 801 MODULE. 1 PATIENT TESTED ON AN INVESTIGATION SITE'S COBAS 8000 E 601 MODULE COMPARED TO THE SIEMENS CENTAUR METHOD. FOR THE 2 PATIENTS, THE PATIENTS' AGES RANGED FROM 26 TO 83 YEARS. THERE WERE 1 FEMALE AND 1 MALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8549734 ↗
• MalfunctionOct 22, 2018High Test Results; High Test Results

  THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR TWO SAMPLES FROM ONE PATIENT FROM THE COBAS 8000 E 801 MODULE. THE SAMPLE WAS THEN TESTED ON AN ARCHITECT ANALYZER AND SUBMITTED FOR INVESTIGATION WHERE IT WAS TESTED ON A COBAS 8000 E 801 MODULE, COBAS 6000 E602 MODULE, AND A COBAS E 411 IMMUNOASSAY ANALYZER. REFER TO THE MEDWATCH WITH THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) ELECSYS TSH ASSAY; (B)(6) ELECSYS FT4 ASSAY; (B)(6) ELECSYS FT3 III. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED AS NO SAMPLE WAS AVAILABLE FOR FURTHER INVESTIGATION. FROM THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7991552 ↗
• MalfunctionOct 16, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS E 801 MODULE. THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS FT3 III (FT3 III) AND ELECSYS FT4 II (FT4 II) BETWEEN THE CUSTOMER'S E801 MODULE AND AN E801 MODULE USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT4 II. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE FT4 II REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 303203 WITH AN EXPIRATION DATE OF APR-2019. BASED ON THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970641 ↗
• MalfunctionSep 28, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED HIGH RESULTS FOR 2 PATIENTS TESTED FOR ELECSYS FT4 II ON A COBAS E801 MODULE. PATIENT 1: ON (B)(6) 2018 PATIENT 1 HAD AN FT4 II RESULT OF 38.6 PMOL/L. ON (B)(6) 2018 PATIENT 1 HAD AN FT4 II RESULT OF 37.4 PMOL/L. ON (B)(6) 2018 PATIENT 1 HAD AN FT4 II RESULT OF 44.0 PMOL/L. ON (B)(6) 2018 PATIENT 1 HAD AN FT4 II RESULT OF 44.3 PMOL/L. THE SAMPLE FROM (B)(6) 2018 WAS SENT TO ANOTHER LABORATORY USING THE VITROS METHOD AND THE FT4 RESULT WAS 13.4 PMOL/L. PATIENT 2 (MALE, (B)(6)): ON (B)(6) 2018 PATIENT 2 HAD AN FT4 II RESULT OF 38.9 PMOL/L. ON (B)(6) 2018 PATIENT 2 HAD AN FT4 II RESULT OF 44.7 PMOL/L. PATIENT 2 WAS TESTED USING THE VITROS METHOD AND THE FT4 RESULT WAS 13.1 PMOL/L. IT IS NOT KNOWN IF THIS RESULT IS FROM A NEW SAMPLE OR THE SAMPLE FROM (B)(6) 2018. THE HIGH RESULTS FROM THE E801 MODULE WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E801 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919355 ↗
• MalfunctionSep 24, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT3 III (FT3 III), ELECSYS FT4 II (FT4 II) AND ELECSYS TSH (TSH) ON A COBAS E801 MODULE. BASED ON THE DATA PROVIDED, DISCREPANT FT4 II RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD AND AN E801 MODULE USED AT THE INVESTIGATION SITE. THE INITIAL FT4 II RESULT FROM THE CUSTOMER SITE WAS REPORTED OUTSIDE OF THE LABORATORY. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT4 II REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 303203 WITH AN EXPIRATION DATE OF APR-2019. FROM THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. ASSAYS FROM DIFFERENT MANUFACTURERS, IN THIS CASE SIEMENS, CAN GENERATE DIFFERENT RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901325 ↗
• MalfunctionAug 15, 2018High Test Results; High Test Results

  THE CUSTOMER COMPLAINED OF A QUESTIONABLE ELECSYS TSH ASSAY RESULT AND A QUESTIONABLE ELECSYS FT4 II ASSAY RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO THE RESULTS FROM AN ARCHITECT ANALYZER AND A SIEMENS CENTAUR ANALYZER. THIS MEDWATCH WILL COVER FT4 II. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER'S COBAS E801 SERIAL NUMBER WAS NOT PROVIDED. THE COBAS E801 SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT4 II REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 265662 WITH AN EXPIRATION DATE OF FEB-2019. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785797 ↗
• MalfunctionAug 10, 2018High Test Results; High Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO SAMPLES FROM ONE PATIENT AND ONE SAMPLE FROM A SECOND PATIENT TESTED FOR ELECSYS FT3 III AND THE ELECSYS FT4 II ASSAY ON A COBAS 8000 E 801 MODULE AT THE CUSTOMER SITE AND AN UNKNOWN ROCHE COBAS ANALYZER AT A SECOND SITE. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ENDOCRINOLOGIST COMPLAINED THAT THE FT3 AND FT4 RESULTS WERE IMPLAUSIBLY HIGH COMPARED TO RESULTS GENERATED ON AN ABBOTT ARCHITECT ANALYZER AT THE SECOND SITE. THE CUSTOMER BELIEVES THAT AN ANTIBODY INTERFERENT IS PRESENT IN THE SAMPLES. THIS MEDWATCH WILL APPLY TO THE FT4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO FT3. THE ERRONEOUS DATA IS HIGHLIGHTED IN YELLOW. FOR PATIENTS 1 AND 2, SAMPLES EACH DATED(B)(6) 2018 WERE TESTED AT THE CUSTOMER SITE ON THE E801 ANALYZER. THE SAMPLES WERE THEN SENT TO A SECOND SITE FOR TESTING ON AN UNKNOWN ROCHE COBAS ANALYZER AND AN ABBOTT ARCHITECT ANALYZER. FT3 AND FT4 RESULTS FOR THESE SAMPLES WERE WITHIN REFERENCE RANGES FOR THE ABBOTT ASSAYS. AT THE SECOND SITE, THE SAMPLES WERE ALSO TREATED WITH HETEROPHILIC ANTIBODY BLOCKING TUBES (HBT) AND TEST

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7772395 ↗
• MalfunctionJul 20, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT4 II (FT4 II), TSH, ANTI-TPO AND ANTI-TSHR ON A COBAS E 801 MODULE. REFER TO THE ASSOCIATED MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS: (B)(6). BETWEEN (B)(6) 2017 AND (B)(6) 2018 THE PATIENT HAD INCREASED FT4 II RESULTS (29-52 PMOL/L) AND LOW TSH RESULTS (0.04 - 0.17 MIE/L) IN 14 DIFFERENT SAMPLES FROM THE PATIENT WHEN TESTED ON THE E801 MODULE. ANTI-TPO RESULTS WERE > 600 IE/ML IN 6 DIFFERENT SAMPLES FROM THE PATIENT WHEN TESTED ON THE E801 MODULE. THE PATIENT PREVIOUSLY HAD NEGATIVE ANTI-TSHR RESULTS IN 2 DIFFERENT SAMPLES WHEN TESTED BY THE (B)46) METHOD, HOWEVER, WHEN THE CUSTOMER CHANGED TO THE ROCHE METHOD IN (B)(6) 2017, THE PATIENT HAD POSITIVE ANTI-TSHR IN 7 DIFFERENT SAMPLES WHEN TESTED ON THE E801 MODULE. THE ACTUAL RESULTS WERE NOT PROVIDED. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PATIENT WAS DIAGNOSED WITH HYPERTHYROIDISM AND TREATMENT WAS STARTED WITH NEO-MERCAZOLE IN (B)(6) 2017. THE CUSTOMER SUSPECTS AN INTERFERENCE IN THE PATIENT SAMPLE AS THE PATIENT'S CLINICAL SYMPTOMS DO NOT AGREE WITH THE RESULTS. THE CUSTOMER SENT 3 PATIENT SAMPLES OBTAINED IN (B)(6) 2018 AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7706293 ↗
• MalfunctionJul 19, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER COMPLAINED OF QUESTIONABLE THYROID RESULTS FOR 2 PATIENT SAMPLES TESTED ON A COBAS 8000 E 801 MODULE AND A COBAS 8000 E 601 COMPARED TO A SIEMENS CENTAUR. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR ELECSYS TSH ASSAY (TSH), ELECSYS T3 (T3), ELECSYS T4 ASSAY (T4), AND ELECSYS FT4 II ASSAY (FT4 II). MEDWATCHES RELATED TO THIS ISSUE INCLUDED PATIENT IDENTIFIERS (B)(6). THE ERRONEOUS RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 SERIAL NUMBER WAS (B)(4). THE COBAS E601 SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS CURRENTLY ONGOING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702327 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED HIGH RESULTS FOR MULTIPLE PATIENTS TESTED FOR EITHER ELECSYS FT4 II OR ELECSYS FT4 III ON A COBAS 8000 E 602 MODULE. THE CUSTOMER THINKS THE ROCHE RESULTS ARE FALSELY ELEVATED AND SENT ALL PATIENT RESULTS ABOVE THE REFERENCE RANGE TO AN EXTERNAL LABORATORY FOR TESTING USING AN UNSPECIFIED METHOD. THE CUSTOMER PROVIDED DATA GENERATED BETWEEN APR-2018 WITH THE FT4 II ASSAY AND MAY-2018 WITH THE FT4 III ASSAY FOR 67 PATIENT SAMPLES. BASED ON THE DATA PROVIDED, THE RESULTS FOR 64 PATIENT SAMPLES WERE DISCREPANT WHEN TESTED FOR FT4 II OR FT4 III. THIS MEDWATCH WILL COVER FT4 II. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT4 III RESULTS. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. IT IS NOT CLEAR IF THE HIGH RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E602 MODULE SERIAL (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691226 ↗
• MalfunctionJul 12, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 6 PATIENT SAMPLES TESTED FOR ELECSYS FT4 II (FT4 II), ELECSYS FT3 III (FT3 III) AND ELECSYS TSH (TSH) ON A COBAS E 801 MODULE. THE 6 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR FT4 II, FT3 III AND TSH BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT4 II. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION ON THE TSH ERRONEOUS RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR INFORMATION ON THE FT3 III ERRONEOUS RESULTS. REFER TO ATTACHED DATA TITLED "PATIENT RESULTS" FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE SERIAL NUMBER FOR THE CUSTOMER'S E801 MODULE WAS NOT PROVIDED. THE PATIENT SAMPLES WERE ALSO TREATED AND UNDERWENT POLYETHYLENE GLYCOL (PEG) TESTING. REFER TO ATTACHED DATA TITLED "PEG TESTING" FOR THESE RESULTS. THE E602 MODULE SERIAL NU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7680857 ↗