Elecsys ACTH 07026684190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630939893), received between Jul 25, 2022 and Dec 29, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS ACTH (ACTH) ON A COBAS E 801 ANALYTICAL UNIT. THE ACTH RESULTS ARE ALLEGEDLY HIGH WITH NO KNOWN CAUSE, AS THE PATIENT IS ASYMPTOMATIC (PREVIOUSLY CUSHING'S DISEASE). THE INITIAL RESULT WAS 118,000 PG/ML. THE SAMPLE WAS REPEATED WITH VARIOUS DILUTIONS: X5: > 2000 PG/ML WITH A DATA FLAG, X10: >2000 PG/ML WITH A DATA FLAG, X20: >2000 PG/ML WITH A DATA FLAG, X40: >2000 PG/ML WITH A DATA FLAG, X75: 118,350 PG/ML, X100: 126,400 PG/ML. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT WAS APPROXIMATELY 25,000 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905893 ↗
• MalfunctionJun 5, 2024Non Reproducible Results; Non Reproducible Results

  THERE IS A SUSPECTED INTERFERENCE WITH THE ELECSYS ACTH ASSAY DUE TO QUESTIONABLE RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. ON 15-JUN-2022 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 39480 PG/ML FOLLOWING A DILUTION. ON 15-SEP-2022 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 29000 PG/ML FOLLOWING A DILUTION. ON 10-MAR-2023 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 61050 PG/ML FOLLOWING A DILUTION. ON 28-JUL-2023 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 7375 PG/ML FOLLOWING A DILUTION. ON 16-JAN-2024 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 71850 PG/ML FOLLOWING A DILUTION. THE SAMPLE WAS TESTED USING THE SIEMENS IMMULITE METHOD WITH MULTIPLE DILUTIONS AND THE RESULTS WERE HIGH. THE NUMERIC RESULTS WERE NOT PROVIDED. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19471990 ↗
• MalfunctionJul 25, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ACTH ELECSYS E2G RESULTS FROM A COBAS E 801 MODULE. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE SAMPLE FROM (B)(6) 2022 WAS SENT FOR INVESTIGATION AND TESTED ON A COBAS E 801 MODULE AND A COBAS E 602 MODULE. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR PATIENT DATA. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO THE PHYSICIAN. THE CUSTOMER BELIEVED THE RESULTS FROM (B)(6) 2021 AND (B)(6) 2022 WERE INCORRECT BUT BELIEVED THE RESULTS FROM (B)(6) 2022 WERE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094293 ↗