Elecsys Ferritin 4491785160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630938957), received between Jun 22, 2023 and Sep 18, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low 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.

• MalfunctionSep 18, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FERRITIN RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL FERRITIN RESULT WAS 1.33 NG/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT. THE SAMPLE WAS REPEATED AND THE RESULT WAS 988.4 NG/L. THE SAMPLE WAS ALSO REPEATED ON ANOTHER E601 ANALYZER AND THE RESULT WAS 1010 NG/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250780 ↗
• MalfunctionDec 18, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 6000 E601 MODULE. PATIENT 1 INITIAL HCG+BETA ELECSYS RESULT WAS 3653 MIU/ML AND THE REPEAT RESULT WAS 8505 MIU/ML. PATIENT 2 INITIAL FERRITIN RESULT WAS 1578 NG/ML AND THE REPEAT RESULT WAS 3036 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18346976 ↗
• MalfunctionJun 22, 2023Unable to Obtain Readings; Unable to Obtain Readings

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH ELECSYS FERRITIN (FERR) ASSAY ON A COBAS 6000 COBAS E601 IMMUNOASSAY ANALYZER. INITIAL RESULT: 0.768 NG/ML REPEAT RESULT: 18.65 NG/ML THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER NOTICED THE QUESTIONABLE RESULT WHILE REVIEWING THE TESTING AND THEREFORE, REPEATED THE SAMPLE. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183791 ↗