Iron Gen.2 5169291190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630925049), received between Jan 2, 2025 and Aug 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Non Reproducible 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.

• MalfunctionAug 28, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR IRON GEN.2 (IRON2) ON A COBAS 8000 C702 MODULE. THE INITIAL RESULT FROM THE C702 MODULE WAS 545 UG/DL. THE DOCTOR QUESTIONED THIS RESULT. ON (B)(6) 2025, THE SAMPLE WAS TESTED BY THE BECKMAN METHOD WITH A RESULT OF 267 UG/DL. THE RESULT FROM THE BECKMAN METHOD WAS BELIEVED TO BE CORRECT. ON (B)(6) 2025, THE CUSTOMER DILUTED THE SAMPLE TO TEST FOR INTERFERENCE, AND THE FOLLOWING RESULTS WERE OBTAINED: 1:3 DILUTION = 611 UG/DL, 1:5 DILUTION = 620 UG/DL, 1:10 DILUTION = 564 UG/DL, 1:50 DILUTION = 419 UG/DL. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914263 ↗
• MalfunctionJan 2, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR IRON2 ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 951 UG/DL. THE REPEAT RESULT WAS 58 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054420 ↗