Creatinine Jaff Gen2 4810716190Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04015630922284), received between Jul 27, 2018 and Sep 29, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (8 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 13 most recent of 13 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionSep 11, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREP2 (CREATININE PLUS VER.2) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL CONDITION, PROMPTING THE RERUN OF THE PATIENT SAMPLE. A NEW SAMPLE WAS ALSO COLLECTED FROM THE PATIENT. THE INITIAL RESULT OF THE INITIAL SAMPLE WAS 4.02 MG/DL. THE REPEAT RESULT OF THE INITIAL SAMPLE WAS 0.54 MG/DL. THE RESULT OF THE NEW SAMPLE WAS 0.52 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720353 ↗
• MalfunctionNov 22, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENTS TESTED FOR CREATININE JAFFÉ GEN.2 (CREJ2) ON A COBAS 6000 C (501) MODULE. THE CUSTOMER PROVIDED DISCREPANT RESULTS FOR 2 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 1.29 MG/DL. THE REPEAT RESULT WAS 0.80 MG/DL. PATIENT 2 INITIAL RESULT WAS 1.51 MG/DL. THE REPEAT RESULT WAS 0.95 MG/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE C501 MODULE SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848662 ↗
• MalfunctionNov 7, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE JAFFE, GEN 2 RESULT FROM THE COBAS 4000 C311 SYSTEM. THE INITIAL RESULT WAS 4.43 MG/DL WITH A DATA FLAG AND WAS REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. AS THE RESULT DID NOT COINCIDE WITH THE PATIENT'S MEDICAL HISTORY, THE DOCTOR REQUESTED REPEAT TESTING. ON 13-OCT-2022, THE SAME SAMPLE WAS RETESTED ON THE SAME ANALYZER WITH A RESULT OF 2.09 MG/DL AND ON A COBAS C501 ANALYZER WITH A RESULT OF 1.80 MG/DL. THE REPEAT RESULT WAS BELIEVED CORRECT. THE REAGENT LOT NUMBER WAS 63597001 WITH AN EXPIRATION DATE OF 31-JAN-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15742555 ↗
• MalfunctionJun 17, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULTS FOR TWO SAMPLES FROM ONE PATIENT. THE CUSTOMER QUESTIONED IF THE PATIENT'S MEDICATIONS/TREATMENTS COULD HAVE AFFECTED THE RESULTS. SAMPLE 1 WAS DRAWN AT 01:56 PM AND THE RESULTS WERE 6.16 MG/DL, 6.25 MG/DL, AND 6.59 MG/DL. SAMPLE 2 WAS DRAWN AT 5:12 PM AND THE RESULTS WERE 0.27 MG/DL AND 0.31 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER USED COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14735813 ↗
• MalfunctionFeb 15, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULTS FOR 1 PATIENT ON A COBAS 6000 C501 MODULE, SERIAL NUMBER (B)(4). THE FOLLOWING RESULTS WERE OBTAINED FROM DIFFERENT SAMPLES: ON (B)(6) 2021 THE RESULT WAS 0.72 MG/DL. ON (B)(6) 2021 THE RESULT WAS 0.60 MG/DL. ON (B)(6) 2021 THE RESULT WAS 0.50 MG/DL. ON (B)(6) 2021 THE RESULT WAS 0.47 MG/DL. ON (B)(6) 2022 THE RESULT WAS 0.62 MG/DL. ON (B)(6) 2022 THE RESULT WAS 4.47 MG/DL. ON (B)(6) 2022 THE RESULT WAS 4.51 MG/DL. ON (B)(6) 2022 THE RESULT WAS 7.22 MG/DL. ON (B)(6) 2022 THE RESULT WAS 7.03 MG/DL. ON (B)(6) 2022 THE RESULT WAS 5.58 MG/DL. ON (B)(6) 2022 THE RESULT WAS 6.11 MG/DL AND 6.31 MG/DL. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT'S NEPHROLOGIST DOES NOT BELIEVE THE INCREASING CREATININE RESULTS ARE CORRECT BECAUSE THE PATIENT'S UREA RESULT IS BELOW 10 MG/DL. THE DOCTOR EXPECTS THE PATIENT'S CREATININE RESULT TO BE <1.2 MG/DL. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538872 ↗
• MalfunctionJul 27, 2018Low Test Results; Low Test Results

  THE CUSTOMER RECEIVED A QUESTIONABLE CREJ2 CREATININE JAFFÉ GEN.2 RESULT FOR ONE PATIENT AND A QUESTIONABLE ISE INDIRECT GEN.2 SODIUM RESULT FOR ONE OTHER PATIENT. PATIENT 1 INITIAL CREATININE RESULT WAS 2 MG/DL AND THE REPEAT RESULT WAS 4.2 MG/DL. PATIENT 2 INITIAL SODIUM RESULT WAS 132 MMOL/L AND THE REPEAT RESULT WAS 142 MMOL/L. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT/ELECTRODE LOT NUMBERS AND EXPIRATION DATE DATES WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7725505 ↗