Creatinine plus ver2Recalls & reported problems across all models

We found 3 models of Creatinine plus ver2 by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2018 and Sep 30, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (28 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 plus ver2 problems

Creatinine plus ver2 models

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

• Creatinine plus ver2 5168589190

  ENZYMATIC METHOD, CREATININE
  27 reports
• Creatinine plus ver2 3263991190

  ENZYMATIC METHOD, CREATININE
  25 reports
• Creatinine plus ver2 5401470190

  ENZYMATIC METHOD, CREATININE
  4 reports

Recent Creatinine plus ver2 adverse event reports

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

• MalfunctionSep 30, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949998 ↗
• MalfunctionSep 2, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570995 ↗
• MalfunctionDec 23, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR QC AND PATIENT SAMPLES FROM THE COBAS 8000 COBAS C 701 MODULE. ONE EXAMPLE WAS AN INITIAL RESULT OF 0.79 MG/DL AND A REPEAT RESULT OF 0.96 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881688 ↗
• MalfunctionDec 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE PLUS VER.2 RESULT FROM THE COBAS INTEGRA 400 PLUS FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 2.02 MG/DL, AND THE REPEAT RESULT WAS 1.0 MG/DL. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 1.21 MG/DL, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 0.59 MGDL. THE CUSTOMER ALSO PROVIDED QUESTIONABLE URIC ACID VER.2 RESULTS FOR ONE PATIENT AND CALCIUM GEN.2 RESULTS FOR ONE PATIENT. THIS MEDWATCH WILL COVER THE CREATININE PLUS VER.2 ASSAY. SEE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE URIC ACID VER.2 ASSAY. SEE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE CALCIUM GEN.2 ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876623 ↗
• MalfunctionDec 21, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR CREATININE PLUS VER.2 (CREP2) ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 9.94 MG/DL. THE PHYSICIAN QUESTIONED THIS RESULT. THE SAMPLE WAS REPEATED ON A DIFFERENT C MODULE WITH A RESULT OF 1.34 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860439 ↗
• MalfunctionDec 15, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. A SERUM SAMPLE WAS COLLECTED FROM A PATIENT UNDERGOING ELTROMBOPAG THERAPY. THE SAMPLE WAS COFFEE-BROWN IN COLOR. THE INITIAL RESULT WAS APPROXIMATELY 120 UMOL/L. THE CUSTOMER ALLEGED THAT THE C 502 ANALYZER FAILED TO DETECT THE SAMPLE DISCOLORATION, AND THE CLINIC WAS ADVISED TO REQUEST CREATININE RESULTS USING A BLOOD GAS ANALYZER. THE SAMPLE WAS REPEATED ON AN UNKNOWN BLOOD GAS ANALYZER, RESULTING IN A CREATININE VALUE OF APPROXIMATELY 160 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801192 ↗
• MalfunctionDec 1, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 (CREP) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. AN INTERFERENCE WITH THE CREATININE PLUS VER.2 ASSAY WAS SUSPECTED. THE INITIAL RESULT WAS 97 UMOL/L. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE IT DIDN'T MATCH THE PATIENT'S CLINICAL CONDITION. THE SAMPLE WAS REPEATED ON AN AU ANALYZER (BECKMAN COULTER), AND THE RESULTS WERE 201 UMOL/L AND 197 UMOL/L. THESE RESULTS WERE BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED ON ANOTHER COBAS 8000 C702 MODULE, AND THE RESULT WAS 93 UMOL/L. ON (B)(6) 2025, THE SAMPLE WAS REPEATED ON THE SAME COBAS 8000 C702 MODULE AS THE INITIAL RESULT. THE CREP ASSAY RESULT WAS 94 UMOL/L, AND THE CRE-J ASSAY RESULT WAS 212 UMOL/L. THE SAMPLE WAS REPEATED WITH THE CREP ASSAY ON A COBAS C503 MODULE, AND THE RESULT WAS 96.1 UMOL/L. THE CREATININE ASSAY USED ON THE COBAS 8000 C702 MODULE WAS CREP (ENZYMATIC ASSAY), WHILE THE ASSAY USED ON THE AU ANALYZER WAS CRE-J.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23684655 ↗
• MalfunctionNov 11, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE THE INITIAL RESULT WAS 15.83 MG/DL. THE REPEAT RESULT WAS 0.92 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526040 ↗
• MalfunctionNov 4, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2 ON A COBAS 8000 C 701 MODULE. THE SAMPLE INITIALLY RESULTED IN A CREATININE RESULT OF 6.48 MG/DL. THE VALUE WAS QUESTIONED BY THE PATIENT'S PROVIDER AS THE VALUE DID NOT AGREE WITH THE PATIENT'S HISTORY AND A VALUE OF 4.16 MG/DL MEASURED FROM A SECOND SAMPLE COLLECTED FROM THE PATIENT. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A CREATININE VALUE OF 4.3 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468609 ↗
• MalfunctionAug 14, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FOR ONE SAMPLE FROM THE COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 434.8 UMOL/L, AND THE REPEAT RESULT WAS 62.3 UMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802464 ↗
• MalfunctionJun 3, 2025High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATININE PLUS VER.2 (CREP2) ASSAY ON A COBAS 6000 C501 MODULE. INITIAL RESULT: 425.4 ¿MOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AND REPEATED THE SAMPLE. REPEAT RESULT: 74.3 ¿MOL/L. THE REPEAT RESULT OF 74.3 ¿MOL/L WAS DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULT WAS ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131213 ↗
• MalfunctionApr 25, 2025Low Test Results; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLES TESTED WITH CREATININE PLUS VER.2 (CREP2) ASSAY ON A COBAS 8000 C702 MODULE WHEN COMPARED TO A COBAS C501 MODULE AND ARCHITECT SYSTEM. SAMPLE 1 WAS INITIALLY TESTED ON C501 RESULTING IN VALUES OF 325 UMOL/L AND 336 UMOL/L. SAMPLE 1 WAS REPEATED USING A DILUTION FACTOR OF 1:50 ON THE C501 AND THE RESULT WAS 355 UMOL/L (ACCOMPANIED BY A DATA FLAG). THE PHYSICIAN QUESTIONED THE RESULT OF 325 UMOL/L AS IT DID NOT CORRELATE WITH THE PATIENT'S CLINICAL PICTURE AND REQUESTED A 2ND SAMPLE (SAMPLE 2) TO BE DRAWN. SAMPLE 2 WAS TESTED ON THE C501 RESULTING IN VALUES OF 34 UMOL/L AND 35 UMOL/L. SAMPLE 1 WAS THEN REPEATED RESULTING IN VALUES OF: 24 UMOL/L AND 27 UMOL/L WHEN TESTED ON C702. 411.2 UMOL/L WHEN TESTED ON ARCHITECT. SAMPLE 2 WAS ALSO REPEATED ON C702 AND ARCHITECT RESULTING IN VALUES AROUND 35 UMOL/L TO 40 UMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912952 ↗
• MalfunctionMar 20, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. THE INITIAL RESULT WAS 1.31 MG/DL. THE REPEAT RESULT FROM ANOTHER C701 ANALYZER WAS 0.82 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652720 ↗
• MalfunctionNov 26, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS INTEGRA CREATININE PLUS VER.2 ASSAY RESULTS FOR 1 PATIENT ON A COBAS INTEGRA 400 PLUS ANALYZER. THE INITIAL RESULT WAS 2.23 MG/DL USING A LITHIUM HEPARIN PLASMA TUBE. THE REPEATED RESULT WAS 0.46 MG/DL USING A PLASMA ETHYLENEDIAMINETETRAACETIC ACID (EDTA) TUBE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 2.13 MG/DL USING A LITHIUM HEPARIN PLASMA TUBE AND 0.45 MG/DL USING A PLASMA ETHYLENEDIAMINETETRAACETIC ACID (EDTA) TUBE. A NEW SAMPLE WAS TESTED AND THE PLAIN SERUM TUBE RESULT WAS 0.44 MG/DL. IT WAS REPORTED THAT THE RESULT FROM THE PLASMA EDTA TUBE WAS ALMOST THE SAME BUT A NUMERICAL VALUE WAS NOT PROVIDED. THE CUSTOMER CONSIDERED THE RESULT FROM THE PLAIN SERUM TUBE (0.44 MG/DL) AND THE EDTA TUBE RESULTS (0.46 MG/DL AND 0.45 MG/DL) TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788810 ↗
• MalfunctionNov 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH CREATININE PLUS VER.2 (CREP2) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. PATIENT 1: INITIAL RESULT: 361.9 MOL/L. REPEAT RESULT: 174.3 MOL/L. PATIENT 2 WAS TESTED ON (B)(6) 2024: INITIAL RESULT: 245.9 MOL/L. 1ST REPEAT RESULT: 60 MOL/L. 2ND REPEAT RESULT: 59 MOL/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS AS BOTH PATIENTS WERE NOT RENAL PATIENTS AND REQUESTED THE SAMPLE TO BE REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622632 ↗

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