Elecsys Cortisol II 07027150190Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04015630939985), received between May 26, 2022 and Sep 28, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917895 ↗
• MalfunctionJan 12, 2026Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CORTISOL II ASSAY RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 9.22 UG/L. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 252 UG/L AND 258 UG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038706 ↗
• MalfunctionDec 22, 2025High Test Results; Low Test Results; High Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY, ELECSYS FT3 III ASSAY, ELECSYS VITAMIN D TOTAL III ASSAY, ELECSYS SHBG ASSAY, ELECSYS TESTOSTERONE II ASSAY, ELECSYS CORTISOL II ASSAY, ELECSYS PROLACTIN II ASSAY, ELECSYS FSH ASSAY, AND ELECSYS ANTI-TG ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE CORTISOL II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE VITAMIN D TOTAL III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE SHBG ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TESTOSTERONE II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 III ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE PROLACTIN II ASSAY, TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FSH ASSAY, AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866577 ↗
• MalfunctionDec 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CORTISOL III RESULTS FOR 2 SAMPLES FROM THE SAME PATIENT ON A COBAS PURE E 402 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE INITIAL LOW RESULTS WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLES. SAMPLE 1 HAD AN INITIAL RESULT OF 26.2 NMOL/L. THE FIRST REPEAT RESULT WAS >1750 NMOL/L. A 1:10 DILUTION WAS PERFORMED ON THE SAMPLE AND THE RESULT WAS >17500 NMOL/L. A 1:100 DILUTION WAS PERFORMED ON THE SAMPLE AND THE RESULT WAS 20272 NMOL/L WITH FLAG. SAMPLE 2 HAD AN INITIAL RESULT OF 28.3 NMOL/L. THE REPEAT RESULT WAS 566 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810641 ↗
• MalfunctionNov 20, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CORTISOL II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.5 NMOL/L WITH A DATA FLAG. THE CLINICIAN REQUESTED THAT THE SAMPLE BE REPEATED. THE REPEATED RESULT WAS 368 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606628 ↗
• MalfunctionJul 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; High Readings; Low Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; High Readings; Low Readings; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CORTISOL II RESULTS FOR 4 PATIENT SAMPLES ON A COBAS E 801 MODULE. ON (B)(6) 2025, THE CUSTOMER PERFORMED QC AND OBSERVED LOW RESULTS, WHICH PROMOTED THEM TO REPEAT PATIENT SAMPLES PREVIOUSLY RUN FROM 03-JUL TO (B)(6) 2025. FOR PATIENT 1, THE INITIAL CORTISOL RESULT WAS 7.20 NMOL/L. THE REPEAT RESULT WAS 1.50 NMOL/L. FOR PATIENT 2, THE INITIAL CORTISOL RESULT WAS 5.60 NMOL/L. THE REPEAT RESULT WAS 1.50 NMOL/L. FOR PATIENT 3, THE INITIAL CORTISOL RESULT WAS 17.00 NMOL/L. THE REPEAT RESULT WAS 4.40 NMOL/L. FOR PATIENT 4, THE INITIAL CORTISOL RESULT WAS 6.40 NMOL/L. THE REPEAT RESULT WAS 1.50 NMOL/L. THE EXACT DATES OF INITIAL TESTING OF THE PATIENT SAMPLES AND INFORMATION ON WHICH RESULTS WERE DEEMED CORRECT WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664343 ↗
• MalfunctionOct 17, 2024High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ACTH (ACTH) AND ELECSYS CORTISOL II (CORTISOL II) COMPARED TO OTHER SAMPLES FROM THE PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER CORTISOL II. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-(B)(6) FOR INFORMATION ON THE ACTH RESULTS. ON 03-SEP-2024 THE ACTH RESULT WAS 3 PG/ML AND THE CORTISOL II RESULT WAS 7 UG/DL. ON 10-SEP-2024 THE ACTH RESULT WAS 270 PG/ML. THE REPEAT ON 11-SEP-2024 WAS 130 PG/ML. ON 10-SEP-2024 THE CORTISOL II RESULT WAS 105 UG/DL. ON 11-SEP-2024 THE ACTH RESULT WAS 6 PG/ML AND THE CORTISOL II RESULT WAS 6 UG/DL. THE SAMPLE FROM 10-SEP-2024 WAS SUBMITTED FOR INVESTIGATION AND TESTED ON AN E801 MODULE. THE ACTH RESULT WAS 101 PG/ML. THE CORTISOL II RESULT WAS 111 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473593 ↗
• MalfunctionOct 8, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CORTISOL II RESULTS FOR 1 PATIENT ON A COBAS 8000 E 801 MODULE. AN INTERFERENCE WITH DHEAS (DEHYDROEPIANDROSTERONE SULFATE) AND DELTA 4 ANDROSTENDIONE WAS SUSPECTED. THE ELECSYS CORTISOL II RESULT WAS 17298 NMOL/L. THIS RESULT WAS BELIEVED TO BE INCORRECT. THE LC-MS/MS (LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY) RESULT WAS 6505 NMOL/L. IT WAS NOTED THAT THE CUSTOMER HAS APPROXIMATELY 51,000 NMOL/L OF DHEAS IN LC-MS/MS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401430 ↗
• MalfunctionFeb 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CORTISOL G2 ELECSYS RESULTS FROM THE COBAS 8000 CORE UNIT. THE SERUM AND PLASMA SAMPLES WERE COLLECTED FROM THE SAME PATIENT AT THE SAME TIME. THE INITIAL RESULT FROM A SERUM SAMPLE WAS 3.00 G/DL AND THE REPEAT RESULT WAS 3.22 G/DL. THE INITIAL RESULT FROM A PLASMA SAMPLE WAS 13.4 G/DL AND THE REPEAT RESULT WAS 13.9 G/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758664 ↗
• MalfunctionSep 29, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH ELECSYS CORTISOL II ON AN UNKNOWN ROCHE ELECSYS ANALYZER. THE FOURTH PATIENT SAMPLE ALSO HAD DISCREPANT RESULTS WHEN TESTED ON A COBAS E801 MODULE USED FOR INVESTIGATION. THE RESULTS DID NOT AGREE WITH RESULTS OBTAINED WITH A COMPETITOR METHOD (SIEMENS). THE FIRST SAMPLE RESULTED IN A CORTISOL VALUE OF 4.57 UG/L WHEN TESTED WITH THE ROCHE ASSAY. WHEN TESTED WITH THE SIEMENS ASSAY, THE SAMPLE RESULTED IN A CORTISOL VALUE OF 28.1 UG/DL. THE SECOND SAMPLE RESULTED IN A CORTISOL VALUE OF 3.82 UG/L WHEN TESTED WITH THE ROCHE ASSAY. WHEN TESTED WITH THE SIEMENS ASSAY, THE SAMPLE RESULTED IN A CORTISOL VALUE OF 9.0 UG/DL. THE THIRD SAMPLE RESULTED IN A CORTISOL VALUE OF 2.59 UG/L WHEN TESTED WITH THE ROCHE ASSAY. WHEN TESTED WITH THE SIEMENS ASSAY, THE SAMPLE RESULTED IN A CORTISOL VALUE OF 11.3 UG/DL. AN ALIQUOT OF THE FOURTH SAMPLE (TUBE A) RESULTED IN A CORTISOL VALUE OF 2.39 UG/DL WHEN TESTED WITH THE ROCHE ASSAY ON (B)(6) 2023. A SECOND ALIQUOT OF THE SAME SAMPLE (TUBE B) WAS TESTED WITH THE SIEMENS ASSAY ON (B)(6) 2023, RESULTING IN A CORTISOL VALUE OF 16.3 UG/DL. THE 2 ALIQUOTS OF THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848209 ↗
• MalfunctionSep 26, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CORTISOL II RESULTS FROM TWO PATIENT SAMPLES (SALIVA) TESTED ON THE COBAS E 801 MODULE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THEY WERE CONSIDERED INCORRECT. PATIENT 1: ON (B)(6) 2023, THE INITIAL RESULT WAS 322 NMOL/L. ON (B)(6) 2023, THE REPEAT RESULT WAS 2 NMOL/L. PATIENT 2: ON (B)(6) 2023, THE INITIAL RESULT WAS 373 NMOL/L. THE REPEAT RESULT WAS 5.2 NMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816623 ↗
• MalfunctionSep 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Optical Problem; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Optical Problem; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 11 PATIENT SAMPLES TESTED WITH ELECSYS CORTISOL II ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE PATIENT SAMPLES WERE FIRST TESTED ON E 801 ANALYZER #1 AND THEN REPEATED ON E 801 ANALYZER #2. THE SAMPLES WERE THEN TESTED USING COMPETITOR METHODS, INCLUDING AN ABBOTT ARCHITECT, AN ALINITY ANALYZER, AND AN UNKNOWN METHOD TITLED "AMPATH". THE E 801 ANALYZER RESULTS DID NOT AGREE WITH RESULTS OBTAINED WITH COMPETITOR METHODS. CORTISOL REAGENT LOT NUMBER 66921801, WITH AN EXPIRATION DATE OF 30-NOV-2023 WAS USED ON E 801 ANALYZER #1. CORTISOL REAGENT LOT NUMBER 70917801, WITH AN EXPIRATION DATE OF 31-MAR-2024 WAS USED ON E 801 ANALYZER #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769154 ↗
• MalfunctionMay 2, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE LOW RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS CORTISOL II ON COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(6). SAMPLES COLLECTED FROM THESE PATIENTS IN THE MORNING WILL HAVE LOW CORTISOL VALUES. WHEN COLLECTING SAMPLES FROM THESE PATIENTS IN THE AFTERNOON, THE RESULTS ARE HIGHER AND WITHIN THE NORMAL EXPECTED RANGE OF THE ASSAY. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE THAT HAD A QUESTIONABLE RESULT. THE COMPLAINED SAMPLE RESULTED IN CORTISOL VALUES OF 4.52 UG/DL AND 4.63 UG/DL. THE 4.63 UG/DL VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE ENDOCRINOLOGIST. THE VALUE DID NOT AGREE WITH THE PATIENT'S HISTORY. A SECOND SAMPLE COLLECTED FROM THE SAME PATIENT IN THE AFTERNOON RESULTED IN A CORTISOL VALUE OF 8.71 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16855050 ↗
• MalfunctionApr 5, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES FROM ONE PATIENT TESTED WITH THE ELECSYS CORTISOL II ASSAY ON A COBAS E 801 ANALYTICAL UNIT (SERIAL NUMBER). AN INTERFERENCE IS SUSPECTED AS THE COBAS E 801 RESULTS DID NOT AGREE WITH THE CLINICAL STATUS OF THE PATIENT. ON (B)(6) 2023 A SAMPLE FROM THE PATIENT RESULTED IN A CORTISOL II VALUE OF 1174 MMOL/L. ON (B)(6) 2023 A SAMPLE FROM THE PATIENT RESULTED IN A CORTISOL II VALUE OF 1043 MMOL/L. THE SAMPLES WERE ALSO TESTED WITH A COMPETITOR METHOD, RESULTING IN A CORTISOL VALUE OF 600 NMOL/L. NO SPECIFIC DATE WAS PROVIDED. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684184 ↗
• MalfunctionFeb 1, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS CORTISOL II ON A COBAS 8000 E 801 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER NOTED THAT CONTROLS WERE LOWER, BUT STILL ACCEPTABLE. THE SAMPLES WERE THEN INITIALLY TESTED. LATER, THE CUSTOMER NOTED THAT CONTROLS RECOVERED BETTER IN A STANDBY CORTISOL REAGENT PACK, SO THEY DECIDED TO REPEAT THE SAMPLES. THE RESULTS WERE DISCREPANT. THE CUSTOMER THEN CHANGED THE REAGENT PACK THAT WAS INITIALLY USED AND THERE WERE NO FURTHER ISSUES. THE FIRST SAMPLE INITIALLY RESULTED IN A CORTISOL VALUE OF 1.63 NMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2023, RESULTING IN A VALUE OF 4.17 NMOL/L. THE SECOND SAMPLE RESULTED IN A CORTISOL VALUE OF 4.64 NMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2023, RESULTING IN A VALUE OF 6.71 NMOL/L. THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280235 ↗
• MalfunctionOct 25, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CORTISOL II ON A COBAS 8000 E 801 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CORTISOL VALUE OF 9 NMOL/L. THE BIOCHEMIST ON DUTY FELT THE RESULT WAS ODD, SO THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 298 NMOL/L. THE CORTISOL REAGENT LOT NUMBER WAS 59557201, WITH AN EXPIRATION DATE OF 31-JAN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15665425 ↗
• MalfunctionMay 26, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CORTISOL II ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER 1795-01). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CORTISOL VALUE OF 1636 NMOL/L WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS REPEATED ON THE E 801 ANALYZER AND THE RESULT WAS THE SAME. THE SAMPLE WAS TESTED USING A LIQUID CHROMATOGRAPHY COUPLED MASS SPECTROSCOPY (LCMS) METHOD, RESULTING IN A VALUE OF 849.4 NMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516116 ↗