Creatinine Jaff Gen2Recalls & reported problems across all models

We found 2 models of Creatinine Jaff Gen2 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 Jul 17, 2018 and Sep 29, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (11 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. 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

Most reported Creatinine Jaff Gen2 problems

Creatinine Jaff Gen2 models

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

• Creatinine Jaff Gen2 4810716190

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  13 reports
• Creatinine Jaff Gen2 6407137190

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  13 reports

Recent Creatinine Jaff Gen2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  There was an allegation of a questionable Creatinine Jaffé Gen.2 result for 1 patient sample on a cobas Integra 400 plus module. The initial result was 0.37 mg/dL. The repeat result was 1.42 mg/dL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931731 ↗
• MalfunctionJan 12, 2026High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FROM 1 PATIENT'S DRAW COLLECTED IN 2 TUBES AND TESTED WITH CREATININE JAFFE GEN.2 ASSAY ON A COBAS 8000 C702 MODULE. THE PATIENT'S DRAW WAS COLLECTED IN 2 DIFFERENT TUBES: TUBE 1 AND TUBE 2. TUBE 1: INITIAL RESULT:1.98 MG/DL. THE PHYSICIAN QUESTIONED THE INITIAL RESULT, AND THE SAMPLE WAS THEN REPEATED. TUBE 2: REPEAT RESULT: 0.88 MG/DL. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24038704 ↗
• MalfunctionDec 18, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED FOR CREATININE JAFFE GEN.2 (CREJ2) ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 4 MG/DL. THE REPEAT RESULT WAS 110 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AS THE INITIAL RESULT WAS LOWER THAN THE REFERENCE RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842988 ↗
• MalfunctionMay 23, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREATININE JAFFE GEN.2 ON A COBAS 8000 C 701 MODULE. THE SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 423 UMOL/L. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025 AND THIS SAMPLE RESULTED IN A CREATININE VALUE OF 63.0 UMO/L. BOTH SAMPLES WERE THEN REPEATED, WITH THE FIRST SAMPLE RESULTING IN A CREATININE VALUE OF 66.7 UMOL/L AND THE SECOND SAMPLE RESULTING IN A VALUE OF 65.1 UMOL/L. THE FIRST SAMPLE WAS REPEATED ON AN UNKNOWN THIRD-PARTY PLATFORM, RESULTING IN A CREATININE VALUE OF 60 UMOL/L. THE LOW VALUES WERE DEEMED CORRECT BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077784 ↗
• MalfunctionJan 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREATININE JAFFÉ GEN. 2 ON A COBAS 8000 C 701 MODULE. IT IS SUSPECTED THAT THE HIGH LIPEMIA IN THE SAMPLE MAY HAVE INTERFERED WITH THE ASSAY. THE AFFECTED SAMPLE HAD INTENSE LIPEMIA, WITH A LIPEMIA INDEX (L INDEX) OF 504 AND A TRIGLYCERIDE CONCENTRATION OF 2736 MG/DL. BASED ON THIS, THE CUSTOMER CENTRIFUGED THE SAMPLE, AND THE ELECTROLYTE TESTS WERE CARRIED OUT USING THE SUPERNATANT. THE DIRECTLY PROCESSED SAMPLE INITIALLY RESULTED IN A CREATININE VALUE OF 0.24 MG/DL. THE VALUE DID NOT AGREE WITH THE PATIENT'S HISTORICAL RESULTS, SO THE CUSTOMER DECIDED TO REPEAT TESTING USING THE SUPERNATANT OF THE CENTRIFUGED SAMPLE. THE REPEAT RESULT WAS 0.86 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103227 ↗
• MalfunctionNov 19, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE LOW CREATININE JAFFÉ GEN. 2 RESULTS FROM 17 PATIENT SAMPLES TESTED ON THE COBAS INTEGRA 400 PLUS. PLEASE REFER TO THE ATTACHMENT "(B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE LOW RESULTS THAT DID NOT MATCH THE PATIENTS' HISTORIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727050 ↗
• MalfunctionOct 10, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT CYSTATIN C GEN. 2 AND CREATININE JAFFÉ GEN. 2 RESULTS FOR 1 PATIENT ON A COBAS 8000 C 701 MODULE THAT WERE USED TO CALCULATE THE (GFR) GLOMERULAR FILTRATION RATE. THE ALLEGED CALCULATED RESULTS DID NOT FIT THE CLINICAL STATUS OF THE PATIENT. SAMPLE 1: ON (B)(6) 2024 THE CYSTATIN C RESULT WAS 2.65 MG/L. THE CALCULATED (GFR) GLOMERULAR FILTRATION RATE WAS 19.9 ML/MIN. SAMPLE 2: ON (B)(6) 2024 THE CYSTATIN C RESULT WAS 2.38 MG/L. THE CALCULATED (GFR) GLOMERULAR FILTRATION RATE WAS 22.9 ML/MIN. THE CREATININE RESULT WAS 0.88 MG/DL. THE CALCULATED (EGFR) GLOMERULAR FILTRATION RATE WAS 72 ML/MIN. SAMPLE 3: ON (B)(6) 2024 THE CYSTATIN C RESULT WAS 2.07 MG/L. THE CALCULATED (GFR) GLOMERULAR FILTRATION RATE WAS 27.6 ML/MIN. THIS MEDWATCH WILL APPLY TO THE CREATININE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TINA-QUANT CYSTATIN C GEN. 2 ASSAY. THE SAMPLES WERE REPEATED DUE TO THE PATIENT HAVING NO KNOWN ILLNESSES AND DID NOT TAKE ANY MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416205 ↗
• MalfunctionSep 25, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 (CREJ2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. ON (B)(6) 2024: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 8.12 MG/DL. THIS RESULT DID NOT FIT THE PATIENT'S HISTORY PROMPTING THE COLLECTION OF A NEW PATIENT SAMPLE AND THE RERUN OF THE INITIAL PATIENT SAMPLE. ON (B)(6) 2024: THE RESULT OF A NEW PATIENT SAMPLE WAS 0.87 MG/DL. THIS RESULT WAS DEEMED CORRECT. THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE WAS 7.97 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305021 ↗
• MalfunctionAug 9, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 (CREJ2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS REPORTED TO THE PATIENT. ON (B)(6) 2024: THE INITIAL RESULT FROM THE MODULE¿S LINE 2 WAS 1.54 MG/DL. ON (B)(6) 2024: THE REPEAT RESULT FROM THE MODULE¿S LINE 4 WAS 1.76 MG/DL. THIS REPEAT RESULT WAS DEEMED CORRECT. ON (B)(6) 2024: THE REPEAT RESULT FROM THE MODULE¿S LINE 2 WAS 2.01 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949353 ↗
• MalfunctionMay 17, 2024Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL CREJ2 RESULT OF 1.64 MG/DL WITH FLAG. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 0.98 MG/DL AND 0.97 MG/DL. ON (B)(6) 2024, SAMPLE 2 HAD AN INITIAL CREJ2 RESULT OF 1.42 MG/DL WITH FLAG. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 0.74 MG/DL AND 0.75 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342436 ↗
• MalfunctionApr 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE JAFFÉ GEN. 2 RESULT FROM THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 14.74 MG/DL AND THE REPEAT RESULT ON ANOTHER COBAS ANALYZER WAS 6.49 MG/DL. THE SAMPLE WAS REPEATED USING ORTHO AND THE RESULT WAS 7.90 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171682 ↗
• MalfunctionApr 5, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFÉ GEN. 2 RESULTS FROM THE COBAS INTEGRA 400 PLUS ANALYZER. THE INITIAL RESULT WAS 1.69 MG/DL. AS THIS RESULT WAS HIGHER THAN EXPECTED, THE SAMPLE WAS REPEATED WITH A RESULT OF 0.71 MG/DL. THE REPEAT RESULT WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053787 ↗
• MalfunctionMar 22, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREP2 (CREATININE PLUS VER.2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY; A COMPLAINT WAS RECEIVED PROMPTING THE RERUN OF THE PATIENT SAMPLE. ON (B)(6) 2024: THE INITIAL RESULT WAS 6.32 MG/DL. THE FIRST REPEAT RESULT WAS 0.59 MG/DL. ON (B)(6) 2024: THE SECOND REPEAT RESULT WAS 0.59 MG/DL. THE REPEAT RESULTS WERE CONSISTENT WITH THE PATIENT'S CLINICAL CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959787 ↗
• MalfunctionDec 13, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 4000 C (311) STAND ALONE SYSTEM. THE INITIAL CREJ2 RESULT WAS 3.07 MG/DL. AN ALIQUOT OF THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.98 MG/DL. ON 19-NOV-2023, THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 3.22 MG/DL. THE PATIENT'S DOCTOR DEEMED THE FIRST REPEAT RESULT AS CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318672 ↗
• MalfunctionOct 23, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH CREATININE (CREAJ2) ASSAY ON A COBAS 8000 C702 ANALYZER. INITIAL RESULT: 18 MOL/L. ON 27-SEP-2023 THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS THEN REPEATED. 1ST RERUN RESULT: 123 MOL/L 2ND RERUN RESULT: 111 MOL/L 3RD RERUN RESULT: 121 MOL/L. AN AMENDED REPORT WITH THE CORRECT RESULT OF 121 MOL/L WAS REPORTED TO THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17988070 ↗

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