Elecsys Cortisol II 6687733160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630940677), received between Aug 23, 2023 and Apr 23, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS CORTISOL II AND ELECSYS ACTH TEST SYSTEM (ACTH) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE ELECSYS CORTISOL II ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS ACTH TEST SYSTEM (ACTH) ASSAY REPORT. THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 24.27 UG/DL (24.3 UG/DL). THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE WAS 23.73 UG/DL. THE RESULT OF A NEW PATIENT SAMPLE WAS 12.51 UG/DL (12.5 UG/DL). THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT, PROMPTING THE PATIENT'S SAMPLE TO BE RERUN. THE RESULT OF THE NEW PATIENT SAMPLE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892558 ↗
• MalfunctionAug 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CORTISOL II ON A COBAS E411 DISK ANALYZER. THE SAMPLE INITIALLY RESULTED IN A CORTISOL VALUE OF 7.93 UG/DL. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 1.51 UG/DL. THE REPEAT VALUE WAS DEEMED CORRECT AND WAS EXPECTED FOR THE PATIENT. THE CUSTOMER RE-CENTRIFUGED THE SAMPLE AND LOCATED A SMALL CLOT IN IT. THE CLOT WAS REMOVED AND THE SAMPLE WAS REPEATED THREE ADDITIONAL TIMES, RESULTING IN CORTISOL VALUES OF 1.53 UG/DL, 2.25 UG/DL, AND 2.39 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604100 ↗