Creatinine Jaff Gen2 compensated) 5401755190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630926824), received between Mar 13, 2024 and Mar 3, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Low Test Results

  THERE WAS AN ALLEGATION OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR CREATININE JAFFE GEN.2 (COMPENSATED) (CREAJ2) ON A COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 0.67 MG/DL. THE REPEAT RESULT FROM A DIFFERENT LABORATORY WAS 1.03 MG/DL. THE REPEAT RESULT AFTER RECALIBRATION WAS 1.02 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500355 ↗
• MalfunctionAug 22, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREATININE JAFFE GEN.2 (COMPENSATED) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 3.2 UMOL/L. THE FIRST REPEAT RESULT WAS 128.2 UMOL/L. THE SECOND REPEAT RESULT WAS 123.5 UMOL/L. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873010 ↗
• MalfunctionAug 11, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFÉ GEN.2 (COMPENSATED) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 111 ANALYZER. THE INITIAL CREATININE RESULT WAS 1.13 MG/DL. THE NEXT DAY, THE SAMPLE WAS REPEATED AND THE RESULT WAS 1.15 MG/DL. THE ANALYZER WAS RECALIBRATED AND AN ALIQUOT OF THE SAMPLE WAS REPEATED AND THE RESULT WAS 1.58 MG/DL. A SEPARATE SAMPLE WAS COLLECTED ON (B)(6) 2025 AND TESTED AT ANOTHER LABORATORY AND THE CREATININE RESULT WAS 0.68 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770707 ↗
• MalfunctionMay 23, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE JAFFE GEN.2 (CREAJ2) ASSAY ON A COBAS C 111 ANALYZER. INITIAL RESULT: 2.73 MG/DL. ON (B)(6) 2025, THE SAMPLE WAS REPEATED. 1ST REPEAT RESULT: 0.50 MG/DL. 2ND REPEAT RESULT: 0.43 MG/DL (TESTED AT ANOTHER BRANCH).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077395 ↗
• MalfunctionNov 4, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFÉ GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 3.90 MG/DL. THE REPEATED RESULT WAS 0.8 MG/DL. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20602179 ↗
• MalfunctionMar 13, 2024Incorrect Measurement; Incorrect Measurement

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH CREATININE JAFFÉ GEN.2 (CREJ2) ASSAY ON A COBAS C111 SYSTEM. INITIAL RESULT: 394.8 MOL/L. THE CUSTOMER DOUBTED THE RESULT. THE SAMPLE WAS REPEATED 3 TIMES AND THE REPEAT RESULTS WERE 90.3 MOL/L, 90.5 MOL/L, AND 89.3 MOL/L. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896332 ↗