Iron Gen.2 08057931190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336121344), received between Jul 25, 2023 and Sep 30, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Low Test Results

  The initial reporter stated they received discrepant results for one patient sample tested with Iron Gen.2 on a cobas pure c 303 analytical unit. No questionable results were reported outside of the laboratory. The sample initially resulted in an Iron value of 23.9 mg/dL. Per laboratory protocol, the customer repeats all samples that initially result in an Iron value of < 25 mg/dL. The sample was repeated and the result was 23.9 mg/dL. Since the results did not match the patient's history, the sample was repeated two additional times. The additional Iron repeat values were 36.3 mg/dL and 39 mg/dL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947871 ↗
• MalfunctionDec 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON GEN.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 607 UG/DL. THE SAMPLE WAS REPEATED THREE TIMES WITH "SAMPLE CLOT" ALARMS. THE SAMPLE WAS RECENTRIFUGED, AND THE REPEAT RESULTS WERE 41.4 UG/DL AND 42.8 UG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT OF 42.8 UG/DL WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876433 ↗
• MalfunctionNov 25, 2025Unable to Obtain Readings; Output Problem; Unable to Obtain Readings; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON GEN.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER SUSPECTED A POSSIBLE INTERFERENCE IN THE SAMPLE. THE FIRST FIVE SAMPLES FROM THIS PATIENT HAD NO ALARM. THEREAFTER, SEVEN CONSECUTIVE SAMPLES FROM THE PATIENT HAD AN ALARM INDICATING "THE CALCULATED VALUES EXCEED THE DEFINED LIMIT.". THREE SUBSEQUENT SAMPLES FROM THE PATIENT HAD NO ALARM. NO SPECIFIC NUMERIC RESULTS WERE PROVIDED. THE CUSTOMER NOTED THAT WHEN THE PATIENT STOPPED TAKING MUCOMYST (ACETYLCYSTEINE), THE ALARM WAS NOT ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647689 ↗
• MalfunctionJan 16, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH IRON2 ON A COBAS PRO C 503 ANALYTICAL UNIT. THE SAMPLE RESULTED IN AN IRON VALUE OF (B)(6). THE VALUE WAS QUESTIONED BY A PHYSICIAN. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2023 AND THE IRON RESULT WAS (B)(6). THE PATIENT'S SAMPLES WERE ALSO TESTED AT ANOTHER CLINIC USING AN UNKNOWN METHOD AND THEY RECEIVED THE SAME RESULTS, WHICH WERE HIGH IRON RESULTS. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521919 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR IRON GEN.2 (IRON2) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 27.5 UG/DL WITH A DATA FLAG. THE REPEAT RESULT WAS 64.9 UG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED TWICE ON A DIFFERENT C503 ANALYZER WITH RESULTS OF 26.0 UG/DL WITH A DATA FLAG AND 26.8 UG/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED TWICE ON THE C503 ANALYZER IN QUESTION WITH RESULTS OF 28.7 UG/DL WITH A DATA FLAG AND 27.4 UG/DL WITH A DATA FLAG. THE INITIAL RESULT OF 27.5 UG/DL WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389633 ↗