Iron Gen.2 3183696122Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04015630918904), received between Aug 3, 2021 and Feb 5, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (12 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Apr 26, 2021Class IIOpen, 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 problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• MalfunctionSep 19, 2023Low Test Results; Calibration Problem; Low Test Results; Calibration Problem

  THERE WAS AN ALLEGATION OF QC ISSUES AND QUESTIONABLE IRON GEN.2 RESULTS FROM THE COBAS INTEGRA 400 PLUS ANALYZER. ONE EXAMPLE WAS AN INITIAL RESULT OF 7 UG/DL AND A REPEAT RESULT OF 53 UG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17776812 ↗
• MalfunctionSep 19, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON2 IRON GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON TWO COBAS INTEGRA 400 PLUS MODULES. FOR SAMPLE 1, THE INITIAL IRON RESULT WAS 3.65 UG/DL. THE SAMPLE WAS REPEATED ON ANOTHER INTEGRA 400 PLUS MODULE AND THE RESULT WAS 14.48 UG/DL. FOR SAMPLE 2, THE INITIAL IRON RESULT WAS 13.46 UG/DL. THE SAMPLE WAS REPEATED ON ANOTHER INTEGRA 400 PLUS MODULE AND THE RESULT WAS 25.30 UG/DL. CLARIFICATION ON WHICH ANALYZER PRODUCED WHICH RESULTS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775455 ↗
• MalfunctionAug 22, 2023Incorrect, 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

  THE INITIAL REPORTER RECEIVED QUESTIONABLE IRON2 IRON GEN.2 (IRON2) RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT SAMPLE 1: THE PATIENT SAMPLE WAS SENT OUT TO ANOTHER LABORATORY THAT USES AN AU480 ANALYZER FOR A RERUN. IT WAS ALSO RERUN ON AN ALINITY ANALYZER. THE INITIAL RESULT FROM THE ANALYZER WAS 0.4 UMOL/L WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 0.6 UMOL/L WITH A DATA FLAG. THE SECOND REPEAT RESULT FROM THE OTHER LABORATORY'S AU480 ANALYZER WAS 2.6 UMOL/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE THIRD REPEAT RESULT FROM THE ALINITY WAS 2.0 UMOL/L. PATIENT SAMPLE 2: THE REPORTER USED A NEW REAGENT PACK (WITH THE SAME LOT NUMBER AS THE PREVIOUS PACK) FOR THE REPEAT RESULT. THE INITIAL RESULT USING THE PREVIOUS REAGENT WAS 0.8 UMOL/L. THE REPEAT RESULT USING THE NEW REAGENT PACK WAS 3.1 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596046 ↗
• MalfunctionJul 12, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON2 IRON GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS INTEGRA 400 PLUS MODULE. THE INITIAL IRON RESULT WAS 3.2 MCG/DL. THE SAMPLE WAS REPEATED ON ANOTHER INTEGRA 400 ANALYZER AND THE RESULT WAS 29.2 MCG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17310423 ↗
• MalfunctionFeb 2, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR GLUC3 GLUCOSE HK GEN.3 (GLUC3) AND IRON2 IRON GEN.2 (IRON2), 1 PATIENT SAMPLE TESTED FOR CREJ2 CREATININE JAFFÉ GEN.2 (CREJ2) AND 1 PATIENT SAMPLE TESTED FOR TINA-QUANT C-REACTIVE PROTEIN IV (CRP4) ON A COBAS INTEGRA 400 PLUS. PATIENT 1 INITIAL GLUC3 RESULT WAS 500 MG/DL. THE REPEAT RESULT WAS 85 MG/DL. THE SAMPLE WAS REPEATED BY THE ABBOTT METHOD WITH A RESULT OF 79 MG/DL. PATIENT 1 INITIAL IRON2 RESULT WAS 5 UG/DL. THE REPEAT RESULT WAS 82 UG/DL. THE QUESTIONABLE RESULTS FOR PATIENT 1 DID NOT MATCH THEIR HISTORICAL RESULTS. ON (B)(6) 2023 PATIENT 2 INITIAL CREJ2 RESULT WAS 80 MG/DL. THE REPEAT RESULT BY THE ABBOTT METHOD WAS 9 MG/DL. NO RESULTS WERE REPORTED. THE RESULTS DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL PICTURE. ON (B)(6) 2023 PATIENT 3 INITIAL CRP4 RESULT WAS 9.89 MG/L. THE REPEAT RESULT WAS 81.08 MG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AS IT MATCHED THE PATIENT¿S HISTORICAL RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE GLUC3 REAGENT LOT NUMBER WAS 60356401 WITH AN EXPIRATION DATE OF 31-MAR-2023. THE IRON2 REAGENT LOT NUMBER WAS 65786

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286750 ↗
• MalfunctionNov 21, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE IRON2 IRON GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS MODULE. ON (B)(6) 2022, PATIENT 1 HAD AN INITIAL IRON RESULT OF 5.82 UG/DL. THE FIRST REPEAT RESULT WAS 7.84 UG/DL AND THE SECOND REPEAT RESULT WAS 42.98 UG/DL. THE SAMPLE WAS SENT TO ANOTHER LAB AND THE IRON RESULT WAS 13.19 UG/DL. ON (B)(6) 2022, PATIENT 2 HAD AN INITIAL IRON RESULT OF 61.74 UG/DL. THE FIRST REPEAT RESULT WAS 0.31 UG/DL. ON (B)(6) 2022, THE SAMPLE WAS REPEATED A SECOND TIME AND THE RESULT WAS 12.83 UG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE IRON REAGENT LOT IS 65786901 AND THE EXPIRATION DATE IS 31-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833179 ↗
• MalfunctionNov 7, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR IRON2 IRON GEN.2 (IRON2) ON A COBAS INTEGRA 400 PLUS. PATIENT 1 INITIAL RESULT WAS 0.46 UG/DL. THE REPEAT RESULT WAS 1.5 UG/DL. THE SAMPLE WAS REPEATED BY AN UNKNOWN METHOD IN ANOTHER LABORATORY WITH A RESULT OF 18.40 UG/DL. PATIENT 2 INITIAL RESULT WAS 9.10 UG/DL. THE REPEAT RESULT WAS 9.96 UG/DL. THE SAMPLE WAS REPEATED BY AN UNKNOWN METHOD IN ANOTHER LABORATORY WITH A RESULT OF 25.30 UG/DL NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE IRON2 REAGENT LOT NUMBER WAS 60819101 WITH AN EXPIRATION DATE OF 31 JAN 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742548 ↗
• MalfunctionJul 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE IRON GEN.2 RESULTS ON A COBAS 6000 C501 (UL) V. THE REPORTER USED PREVIOUS PATIENT SAMPLES TO DO A LOT-TO-LOT CORRELATION. FOR PATIENT #1, THE PREVIOUS IRON RESULT WAS 35 UG/DL. THE REPEAT RESULT ON THE NEW LOT WAS 57 UG/DL. FOR PATIENT #2, THE PREVIOUS IRON RESULT WAS 43 UG/DL. THE REPEAT RESULT ON THE NEW LOT WAS 21 UG/DL. THE PREVIOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS NOT KNOWN WHICH RESULT IS DEEMED CORRECT. THE OLD LOT WAS 59326101 AND THE EXPIRATION DATE IS 30-NOV-2022. THE NEW LOT WAS 60819101 AND THE EXPIRATION DATE IS 31-JAN-2023. THE INSTRUMENT SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14885881 ↗
• MalfunctionAug 3, 2021Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW IRON GEN.2 RESULT FROM COBAS INTEGRA 400 PLUS ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 1.6 MOL/L. THE SAME SAMPLE WAS TESTED IN ANOTHER LABORATORY WITH AN ABBOTT INSTRUMENT AND THE RESULT WAS 6.1 MOL/L. AFTER THE CUSTOMER REPLACED THE REAGENT CASSETTE, THE SAME SAMPLE WAS REPEATED AND THE RESULT WAS EQUAL TO THAT OBTAINED ON THE ABBOTT INSTRUMENT. NO SPECIFIC DATA WAS PROVIDED. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12266276 ↗