Elecsys ACTH Test System 3255751190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630921522), received between Jan 31, 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. How this data works · Data updated Oct 13, 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 ACTH TEST SYSTEM (ACTH) ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CORTISOL II ASSAY REPORT. THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 626.6 PG/ML. THE REPEAT RESULT WAS 581.0 PG/ML. THE RESULT OF A NEW PATIENT SAMPLE WAS 7.33 PG/ML. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PREVIOUS RESULTS, PROMPTING THE PATIENT SAMPLE TO BE RERUN. THE RESULT OF THE NEW PATIENT SAMPLE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892557 ↗
• MalfunctionJan 31, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ACTH TEST SYSTEM (ACTH) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 - COBAS E 602 MODULE WITH SERIAL NUMBER: (B)(4). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN WHO REQUESTED A RERUN. THE REPORTER STATED THAT THEY BELIEVE THERE WAS AN ANALYTICAL INTERFERENCE WITH THE RESULT FROM THIS PATIENT SAMPLE. THE PATIENT SAMPLE WAS ALSO RERUN ON THEIR OTHER E 602 MODULE WITH SERIAL NUMBER: (B)(4), BUT THE REPORTER WAS NOT ABLE TO PROVIDE THE RESULT FROM THIS MODULE. THE PATIENT SAMPLE WAS ALSO SENT TO ANOTHER LABORATORY THAT USES A SIEMENS ANALYZER. THE INITIAL RESULT FROM THE MODULE USING THE PRIMARY TUBE WAS 102.4 PG/ML. THE FIRST REPEAT RESULT FROM THE MODULE USING THE PRIMARY TUBE WAS 101.7 PG/ML. THE SECOND REPEAT RESULT FROM THE OTHER LABORATORY'S ANALYZER USING AN ALIQUOT SAMPLE WAS 64 PG/ML. THE REFERENCE RANGE IS 6-50 PG/ML. THE REPORTER DILUTED THE PATIENT SAMPLES AS PART OF THEIR INVESTIGATION. THE THIRD REPEAT RESULT FROM THE MODULE USING THE PATIENT SAMPLE IN A 1:2 DILUTION WAS 111.6 PG/ML. THE FOURTH REPEAT RESULT FROM THE MODULE USING THE PATIENT SAMPLE IN A 1:4 DILUTION WAS 124.4 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272046 ↗