Iron Gen.2Recalls & reported problems across all models

We found 4 models of Iron Gen.2 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2021 and Sep 30, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (17 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Iron Gen.2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 26, 2021Open, Classified

   Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

   Z-1675-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported Iron Gen.2 problems

Iron Gen.2 models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Iron Gen.2 3183696122

  Photometric method, iron (non-heme)
  1 recall16 reports
• Iron Gen.2 08057931190

  Photometric method, iron (non-heme)
  5 reports
• IRON Gen.2 10059605190

  Photometric method, iron (non-heme)
  3 reports
• Iron Gen.2 5169291190

  Photometric method, iron (non-heme)
  2 reports

Recent Iron Gen.2 adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMar 23, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON GEN.2 RESULTS FROM THE COBAS 6000 C501 MODULE. OF THE DATA PROVIDED, THE RESULTS FOR ONE SAMPLE WERE A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS 171.7 UG/DL, AND THE REPEAT RESULT WAS 174.0 UG/DL. ON (B)(6) 2026, THE REPEAT RESULT WAS 115.0 UG/DL AND WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660837 ↗
• MalfunctionFeb 5, 2026Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE IRON GEN.2 RESULTS FROM FOUR PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. OF THE DATA PROVIDED, THE RESULTS FOR 1 PATIENT SAMPLE WERE DISCREPANT. THE INITIAL RESULT FROM THE ANALYZER WAS 20.4 UG/DL. THE REPEAT RESULT FROM AN EXTERNAL LABORATORY USING A C 8000 SYSTEM WAS 33.4 UG/DL. THE INITIAL RESULT WAS DEEMED LOW, PROMPTING THE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268214 ↗
• 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 ↗
• MalfunctionDec 18, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH IRON GEN.2 ON A COBAS 6000 C501 MODULE. THE SAMPLE INITIALLY RESULTED IN AN IRON VALUE OF 28 UG/DL AND IT ALSO REPEATED AS 28 UG/DL. AT THE CLINICIAN'S REQUEST, THE SAMPLE WAS SENT TO ANOTHER LABORATORY TO REPEAT IT ON A COMPETITOR SYSTEM (ABBOTT). THE IRON RESULT MEASURED WITH THE ABBOTT METHOD WAS 171 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839273 ↗
• MalfunctionDec 4, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON GEN.2 RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE COMPARED TO TWO OTHER ANALYZERS. THE INITIAL RESULT WAS 6 UG/DL. THE REPEAT RESULT FROM TWO OTHER COBAS C502 ANALYZERS WAS 14 UG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE LOW RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714991 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 21, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH IRON GEN.2 (IRON2) ASSAY ON AN INTEGRA 400 PLUS ANALYZER. INITIAL RESULT: 200 G/DL. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. REPEAT RESULT: 100 G/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059736 ↗
• 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 ↗
• MalfunctionAug 7, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON GEN.2 RESULTS FOR 2 SAMPLES TAKEN AT THE SAME TIME FROM 1 PATIENT ON THE COBAS 6000 C501 MODULE. SAMPLE 1 INITIAL RESULT WAS 6.63 UMOL/L. SAMPLE 2 INITIAL RESULT WAS 8.24 UMOL/L. ON (B)(6) 2024, THE SAMPLES WERE REPEATED. SAMPLE 1 REPEAT RESULTS WERE 6.26, 5.90, 5.68, AND 5.90 UMOL/L. SAMPLE 2 REPEAT RESULTS WERE 8.96, 5.74, 5.60, AND 5.57 UMOL/L. ON (B)(6) 2024, THE SAMPLES WERE REPEATED SAMPLE 1 REPEAT RESULT WAS 7.41 UMOL/L. SAMPLE 2 REPEAT RESULT WAS 7.35 UMOL/L. ON 16-JUL, THE SAMPLES WERE TESTED ON A COBAS C702 AT ANOTHER SITE. SAMPLE 1 RESULTS WERE 5.495 AND 5.595 UMOL/L TWICE. SAMPLE 2 RESULTS WERE 5.409 AND 5.314 UMOL/L TWICE. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927577 ↗
• MalfunctionJul 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON2 IRON GEN.2 RESULTS FOR 1 PATIENT ON A COBAS 6000 C501 MODULE. ON (B)(6) 2024, THE INITIAL IRON RESULT WAS 22.67 UMOL/L. THE SAMPLE WAS REPEATED ON A MACCURA ANALYZER AND THE IRON RESULT WAS 95.4 UMOL/L. THE SAMPLE WAS ALSO REPEATED ON A FUJIFILM ANALYZER AND THE IRON RESULT WAS 151.7 UMOL/L. ON (B)(6) 2024, THE INITIAL IRON RESULT WAS 62.93 UMOL/L. THE SAMPLE WAS REPEATED ON A ROCHE 701 ANALYZER AND THE IRON RESULT WAS 73.54 UMOL/L. THE SAMPLE WAS THEN REPEATED ON A MACCURA ANALYZER AND THE IRON RESULT WAS 231.5 UMOL/L. THE SAMPLE WAS ALSO REPEATED ON A FUJIFILM ANALYZER AND THE IRON RESULT WAS 141.82 UMOL/L. ON (B)(6) 2024, THE INITIAL IRON RESULT WAS 36.94 UMOL/L. THE SAMPLE WAS REPEATED ON A MACCURA ANALYZER AND THE RESULT WAS 100 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794425 ↗
• MalfunctionJul 17, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FIVE PATIENT SAMPLES TESTED WITH IRON GEN.2 ON A COBAS INTEGRA 400 PLUS. THE FIRST SAMPLE RESULTED IN AN IRON VALUE OF 0.5 UMOL/L WHEN TESTED ON THE INTEGRA 400 PLUS. THE SAMPLE RESULTED IN AN IRON VALUE OF 2.2 UMOL/L WHEN TESTED AT ANOTHER SITE ON AN UNKNOWN INSTRUMENT. THE SECOND SAMPLE RESULTED IN AN IRON VALUE OF 1.9 UMOL/L WHEN TESTED ON THE INTEGRA 400 PLUS. THE SAMPLE RESULTED IN AN IRON VALUE OF 3.9 UMOL/L WHEN TESTED AT ANOTHER SITE ON AN UNKNOWN INSTRUMENT. THE THIRD SAMPLE RESULTED IN AN IRON VALUE OF 2.1 UMOL/L WHEN TESTED ON THE INTEGRA 400 PLUS. THE SAMPLE RESULTED IN AN IRON VALUE OF 7.0 UMOL/L WHEN TESTED AT ANOTHER SITE ON AN UNKNOWN INSTRUMENT ON (B)(6) 2024. THE FOURTH SAMPLE RESULTED IN AN IRON VALUE OF 1.5 UMOL/L WHEN TESTED ON THE INTEGRA 400 PLUS. THE SAMPLE RESULTED IN AN IRON VALUE OF 7.7 UMOL/L WHEN TESTED AT ANOTHER SITE ON AN UNKNOWN INSTRUMENT ON (B)(6) 2024. THE FIFTH SAMPLE INITIALLY RESULTED WITH AN IRON VALUE OF 1.6 UMOL/L WHEN TESTED ON THE INTEGRA 400 PLUS ON (B)(6) 2024. THE CUSTOMER REPEATED CALIBRATION AND CONTROLS; THESE WERE ACCEPTABLE. THE PRIMARY TUBE OF THE SAMPLE WAS THEN RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763726 ↗
• MalfunctionApr 15, 2024Non 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 6000 C501 MODULE. THE INITIAL RESULT WAS 15.30 UG/DL. THE SAMPLE WAS REPEATED 3 TIMES WITH RESULTS OF 25.90 UG/DL, 16.50 UG/DL, AND 16.10 UG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106477 ↗
• MalfunctionFeb 12, 2024Chemical Problem; Chemical Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 175.47 UG/DL. THE REPEATED RESULT WAS 181.90 UG/DL. THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING ANOTHER METHOD (ATELLICA, SIEMENS) AND THE RESULT WAS 89 MCG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684099 ↗

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