Elecsys Ferritin 3737551160Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630938940), received between Oct 28, 2021 and Jun 2, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE RESULT ELECSYS FERRITIN (FERRITIN) ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT OF THE PATIENT'S FIRST SAMPLE WAS 0.846 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 332.0 NG/ML. THE RESULT OF THE PATIENT'S SECOND SAMPLE WAS 334.2 NG/ML. THE NURSE QUESTIONED THE INITIAL RESULT, PROMPTING THE PATIENT'S SAMPLE TO BE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125323 ↗
• MalfunctionOct 3, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE FERRITIN ELECSYS V2 RESULT FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 1.42 NG/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY AS <2 NG/ML. THE DOCTOR QUESTIONED THE RESULT AND THE REPEAT RESULT WAS 74.18 NG/ML. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860670 ↗
• MalfunctionOct 3, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE RESULT ELECSYS FERRITIN (FERRITIN) FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 RACK. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. A RERUN WAS REQUESTED BY THE LABORATORY RESULTS VALIDATION DEPARTMENT DUE TO AN INITIAL RESULT NOT MATCHING THE PATIENT HISTORY. THE PATIENT'S OTHER SAMPLE WAS ALSO RUN. ON (B)(6) 2023: THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 0.638 NG/ML WITH A DATA FLAG. THE RESULT OF THE OTHER SAMPLE WAS 331.8 NG/ML. ON (B)(6) 2023: THE REPEAT RESULT OF THE INITIAL SAMPLE WAS 336.4 NG/ML. THE INITIAL RESULT WAS DEEMED AN INCORRECT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859481 ↗
• MalfunctionOct 28, 2021High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FERRITIN RESULT FOR ONE PATIENT SAMPLE WITH THE COBAS E411 IMMUNOASSAY ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 25.8 NG/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY AND QUESTIONED AS IT DID NOT MATCH MEDICAL HISTORY. ON (B)(4) 2021, A NEW SAMPLE WAS TESTED WITH A RESULT OF 18.16 NG/ML. ON (B)(4) 2021, THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY AND TESTED WITH AN ARCHITECT WITH A RESULT OF 7.1 NG/ML. ON (B)(4) 2021, THE SAMPLE WAS REPEATED ON ANOTHER E411 AT THE CUSTOMER SITE WITH A RESULT OF 16.78 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12714786 ↗