Creatine KinaseRecalls & reported problems across all models

We found 3 models of Creatine Kinase by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2022 and Sep 22, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 reports).

1 FDA recall record name at least one of these models by its device 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. 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

Creatine Kinase recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 15, 2024Open, Classified

   Creatine Kinase (CK) Assay Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.

   Z-3187-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Creatine Kinase problems

Creatine Kinase models

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

• Creatine Kinase 7190794190

  DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES
  1 recall11 reports
• Creatine Kinase 5168546190

  ENZYMATIC METHOD, CREATININE
  3 reports
• Creatine Kinase 08057460190

  DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES
  1 report

Recent Creatine Kinase adverse event reports

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

• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  There was an allegation of questionable Creatine Kinase results for 12 patient samples on a cobas 4000 c311 stand alone system. As a representative example, three patient results are provided. Patient 1's initial result was 680 U/L.The repeat result from a different c311 was 66 U/L.Patient 2's initial result was 1008 U/L.The repeat result from a different c311 was 97 U/L.Patient 3's initial result was 1890 U/L. The repeat result from a different c311 was 197 U/L.The repeat results were deemed to be correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856428 ↗
• MalfunctionApr 11, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATINE KINASE RESULTS FOR 3 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THE CUSTOMER REPEATED PREVIOUS PATIENT SAMPLES ON A NEW REAGENT LOT AS THEY WERE HAVING ISSUES WITH QC RECOVERING HIGH. SAMPLE 1 HAD AN INITIAL RESULT OF 79.0 U/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 67.5 U/L. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON THE INITIAL ANALYZER WITH A NEW REAGENT LOT AND THE RESULT WAS 59.5 U/L. SAMPLE 2 HAD AN INITIAL RESULT OF 62.0 U/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 48.0 U/L. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON THE INITIAL ANALYZER WITH A NEW REAGENT LOT AND THE RESULT WAS 47.6 U/L. SAMPLE 3 HAD AN INITIAL RESULT OF 15075.0 U/L. ON (B)(6) 2026, THE SAMPLE WAS REPEATED WITH A NEW REAGENT LOT AND THE RESULT WAS 9683 U/L. THE REPEAT RESULTS FROM THE NEW REAGENT LOT WERE DEEMED CORRECT. CLARIFICATION ON WHETHER THE INITIAL RESULTS WERE PRODUCED ON (B)(6)2026 WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851932 ↗
• MalfunctionJul 16, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CREATINE KINASE (CK) ASSAY ON A COBAS 6000 C501 MODULE. INITIAL RESULT: 78 U/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT OF 132,220 U/L. THE PHYSICIAN EXPECTED THE INITIAL RESULT TO BE >100,000 U/L. THE SAMPLE WAS THEN REPEATED AT MULTIPLE DILUTIONS (BOTH WITH AUTO-DILUTION BY THE INSTRUMENT AND MANUAL DILUTION), AND THE REPEAT RESULTS WERE >100,000 U/L. ONE OF THE REPEAT RESULTS WAS 163,985 U/L (ACCOMPANIED BY A DATA FLAG). THE FINAL REPEAT RESULT WAS 181,100 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521887 ↗
• MalfunctionNov 8, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CKMBL CREATINE KINASE-MB RESULTS FOR 1 PATIENT ON A COBAS 6000 C501 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 8712 U/L. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED WITH A 1:10 DILUTION ON ANOTHER MODULE AND THE RESULT WAS 877 U/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULTS WERE: 7249 U/L WITH A DATA FLAG THAT INVALIDATED THE RESULT, 7348 U/L WITH A DATA FLAG THAT INVALIDATED THE RESULT, 7124 U/L WITH A DATA FLAG THAT INVALIDATED THE RESULT, 7108 U/L WITH A DATA FLAG THAT INVALIDATED THE RESULT, 8280 U/L WITH A DATA FLAG THAT INVALIDATED THE RESULT, AND 8374 U/L WITH A DATA FLAG THAT INVALIDATED THE RESULT. SAMPLE 2: A NEW SAMPLE WAS TESTED ON ANOTHER MODULE AND THE RESULT WAS 54 U/L THE SAMPLE WAS REPEATED WITH A 1:10 DILUTION ON ANOTHER MODULE AND THE RESULT WAS 7 WITH A DATA FLAG THAT INVALIDATED THE RESULT. SAMPLE 3: A NEW SAMPLE WAS TESTED ON ANOTHER MODULE AND THE RESULT WAS 61 U/L. THE RESULTS OF "55-60 U/L" WERE CONSIDERED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645570 ↗
• MalfunctionOct 4, 2024Use of Device Problem; Improper or Incorrect Procedure or Method; Non Reproducible Results; Use of Device Problem; Improper or Incorrect Procedure or Method; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CK CREATINE KINASE RESULTS FOR 1 PATIENT ON A COBAS 6000 C (501) MODULE. THE CUSTOMER RECEIVED TWO SERUM TUBES FROM THE SAME PATIENT COLLECTION FOR TWO DIFFERENT TEST PANELS THAT BOTH INCLUDED CK. THE DIFFERENCE IN THE CK VALUES BETWEEN THE TUBES COLLECTED AT THE SAME TIME PROMPTED THEM TO QUESTION THE RESULTS. THE CK RESULT FROM THE FIRST PATIENT SAMPLE WAS 141 U/L. THE CK RESULT FROM THE SECOND PATIENT SAMPLE WAS 70 U/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370521 ↗
• MalfunctionSep 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Material Integrity Problem; Incorrect, Inadequate or Imprecise Result or Readings; Material Integrity Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE CKMBL CREATINE KINASE-MB RESULTS FROM THE COBAS INTEGRA 400 PLUS W/O ISE ANALYZER. THE INITIAL RESULT WAS 6655 UL/L. THE REPEAT RESULT WAS 6569 UL/L AND AFTER CALIBRATION, THE REPEAT RESULT WAS 82 UI/L. ON (B)(6) 2024, THE REPEAT RESULT WAS 7360 UI/L. AFTER ANOTHER CALIBRATION AND CLEANING OF THE INNER AND OUTER WATER TANK, THE REPEAT RESULT WAS 5784 UI/L. FOR THIS TEST, THE CUSTOMER USED A DIFFERENT EDTA SAMPLE FROM THE SAME VENIPUNCTURE. THE RESULT OF 82 UI/L WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148726 ↗
• MalfunctionMay 17, 2024Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE CK CREATINE KINASE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. ON (B)(6) 2024, THE INITIAL CK RESULT WAS 8238 U/L. THE SAMPLE WAS REPEATED WITH AN INCREASED DILUTION AND THE RESULT WAS 3958 U/L. THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 10250 U/L. ON (B)(6) 2024, THE SAMPLE WAS REPEATED A THIRD TIME AND THE RESULT WAS 8256 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345754 ↗
• InjuryDec 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER ALLEGED THERE WAS A DISCREPANT RESULT FOR ONE PATIENT SAMPLE TESTED WITH CK ON A COBAS 8000 C702 MODULE WHICH LED TO A DELAY IN THE PATIENT RECEIVING THE CORRECT DIAGNOSIS AND THE APPROPRIATE TREATMENT. THE PATIENT REPORTEDLY PRESENTED TO THE HOSPITAL WITH WHOLE-BODY ACHES, SPECIFICALLY IN THE ABDOMEN, REDUCED SENSATION AND STRENGTH IN ONE LEG, AND VOMITING. THE PATIENT REPORTEDLY FELL A FEW DAYS BEFORE ADMISSION. THE PATIENT REPORTEDLY HAD A CREATININE VALUE OF APPROXIMATELY 400 UMOL/L AND WAS ALLEGEDLY IN RENAL FAILURE AT THE TIME OF ADMISSION. THE SAMPLE WAS REPORTEDLY COLLECTED FROM THE PATIENT AT THE TIME THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE SAMPLE REPORTEDLY HAD LOW VOLUME, SO THE ANALYSIS WAS PERFORMED WITH THE SAMPLE PLACED INTO A MICRO-CUP ON TOP OF A SAMPLE TUBE. THE SAMPLE INITIALLY RESULTED IN A CK VALUE OF 414.2 U/L. THE PATIENT WAS ALLEGEDLY INCORRECTLY DIAGNOSED WITH COLD SEPSIS DUE TO THE VALUE. A SECOND SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2023 RESULTED IN A CK VALUE OF 99843 U/L, SO THE LOW VALUE FROM THE FIRST SAMPLE WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED ON (B)(6) 2023, RESULTING IN A CK VALUE OF - 305.3 U/L

  Patient problems: Renal Failure

  MAUDE report 18304186 ↗
• MalfunctionDec 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CK ON A COBAS 8000 C702 MODULE. THE CUSTOMER ALLEGES THAT THE RESULTS MAY INDICATE THERE IS AN INTERFERENT IN THE SAMPLE THAT REACTS WITH THE ASSAY. THE SAMPLE INITIALLY RESULTED IN A CK VALUE OF 1026 IU/L ACCOMPANIED BY A DATA FLAG INDICATING THE REACTION LIMIT WAS EXCEEDED. THE SAMPLE REPEATED WITH A CK VALUE OF > 34041 IU/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED X20 AND REPEATED TWICE ON A SECOND ANALYZER, RESULTING IN CK VALUES OF 22 IU/L AND 30 IU/L. THE SAMPLE WAS TESTED AGAIN WITHOUT DILUTION ON THE COMPLAINED ANALYZER, RESULTING IN A CK VALUE OF 30 IU/L. THE SAMPLE WAS DILUTED AGAIN USING AN UNKNOWN DILUTION FACTOR AND REPEATED ON AN UNKNOWN ANALYZER, RESULTING IN A CK VALUE OF 30 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293647 ↗
• MalfunctionSep 12, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE KINASE (CK) RESULTS FOR ONE PATIENT FROM TWO COBAS 501 ANALYZERS. DIFFERENT SAMPLES FROM THE SAME CHILD, TAKEN A FEW HOURS APART, HAD DIFFERENCES IN CK VALUES OF THOUSANDS OF IU. AT 16.00 PM, SAMPLE 1 TESTED ON ANALYZER SERIAL NUMBER (B)(6) HAD A RESULT OF GREATER THAN 5000 IU. THE REPEAT RESULT WITH A DILUTION WAS 5800 IU. THE SAME SAMPLE WAS TESTED WITH A DILUTION ON ANALYZER SERIAL NUMBER (B)(6) AND THE RESULT WAS 6000 IU. SAMPLE 2 WAS DRAWN AT 22.00 PM AND WAS TESTED ON ANALYZER SERIAL NUMBER (B)(6) WITH A RESULT OF 70 IU. THIS SAMPLE WAS THEN TESTED ON ANALYZER SERIAL NUMBER (B)(6) WITH A RESULT OF 68 IU. ON (B)(6) 2023, THE CUSTOMER RETESTED THE SAME SAMPLES. SAMPLE 1 RESULT FROM ANALYZER SERIAL NUMBER (B)(6) WITH A DILUTION WAS 5894 IU. SAMPLE 1 RESULT FROM ANALYZER SERIAL NUMBER (B)(6) WITH A DILUTION WAS 6000 IU. THE RESULT FOR SAMPLE 2 USING ANALYZER SERIAL NUMBER (B)(6) WAS 70 IU. THE RESULT FOR SAMPLE 2 USING ANALYZER SERIAL NUMBER (B)(6) WAS 68 IU. THE RESULT FROM A THIRD SAMPLE DRAWN FROM THE PATIENT AND TESTED ON ANALYZER SERIAL NUMBER (B)(6) WAS 67 IU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731157 ↗
• MalfunctionJun 6, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ISE INDIRECT NA, K AND CI FOR GEN.2 RESULTS FROM AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT ON (B)(6) 2023 AT AROUND NOON, THEY HAD DIFFICULTY CALIBRATING THE NA ASSAY. THEY THEN CHANGED THE "REAGENTS" AND WERE ABLE TO PERFORM A SUCCESSFUL CALIBRATION AND QC. THEY RAN PATIENT SAMPLES THAT NIGHT WHEN A DOCTOR CALLED QUESTIONING A NA RESULT THAT WAS TOO HIGH IN COMPARISON WITH THE POINT OF CARE (POC) RESULT. THE REPORTER THEN RERAN THE PATIENT SAMPLE ON THE OTHER MODULE AND A RESULT DISCREPANCY WAS NOTED. THEY THEN RERAN OTHER PATIENT SAMPLES ON THEIR TWO OTHER C501 MODULES AND NOTED MULTIPLE DISCREPANT NA, AND POSSIBLY A FEW K AND CL RESULTS. THE REPORTER WAS ABLE TO PROVIDE TWO EXAMPLES OF DISCREPANT NA RESULTS. PATIENT SAMPLE 1: THE INITIAL RESULT FROM THE MODULE WAS 148 MMOL/L. THE REPEAT RESULT FROM ONE OF THE TWO OTHER C501 MODULES WAS 140 MMOL/L. PATIENT SAMPLE 1: THE INITIAL RESULT FROM THE MODULE WAS 147 MMOL/L. THE REPEAT RESULT FROM ONE OF THE TWO OTHER C 501 MODULES WAS 139 MMOL/L. THE REPORTER STATED THAT TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073105 ↗
• MalfunctionApr 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH CREATINE KINASE (CK) ASSAY ON A COBAS 6000 C501 (UL) V SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS 19 U/L. THE REPEAT RESULTS WERE 8076 U/L WITH A DATA FLAG AND 9785 U/L. THE RESULTS WERE OBTAINED FROM A SINGLE SAMPLE. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT DEEMED TO BE THE CORRECT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809455 ↗
• MalfunctionApr 12, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE KINASE (CK) RESULT FROM THE COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4). IN THE AFTERNOON AT 18:04, THE INITIAL RESULT FOR SAMPLE 1 WAS 733 U/L (WITH NO DATA FLAG) AND WAS REPORTED OUTSIDE OF THE LABORATORY. LATER IN THE EVENING AROUND 22:00, SAMPLE 2 WAS DRAWN FROM THE PATIENT AND THE CK RESULT WAS 2505 U/L WITH A DATA FLAG. WITH A 1:50 DILUTION, THE RESULT WAS 34941 U/L. SAMPLE 1 WAS THEN REPEATED AT 22:45 WITH A 1:50 DILUTION AND THE RESULT WAS 37337 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726441 ↗
• MalfunctionDec 12, 2022Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CK CREATINE KINASE ON TWO COBAS 6000 C (501) MODULE ANALYZERS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER SUSPECTED THE SAMPLE CONTAINS AN INTERFERING FACTOR AGAINST A COMPONENT OF THE CK ASSAY. THE SAMPLE WAS TESTED ON THE FIRST C 501 ANALYZER, RESULTING IN A VALUE OF < 6 U/L WITH A DATA FLAG. THE SAMPLE WAS TESTED TWICE ON THE SECOND C 501 ANALYZER, EACH TIME RESULTING IN A VALUE OF < 6 U/L WITH A DATA FLAG. A SERIAL NUMBER OF (B)(4) WAS PROVIDED FOR ONE OF THE TWO C 501 ANALYZERS. IT IS NOT KNOWN IF THIS WAS THE FIRST ANALYZER OR THE SECOND ANALYZER USED FOR TESTING. THE SERIAL NUMBER OF THE OTHER C 501 ANALYZER WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959879 ↗
• MalfunctionJul 20, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CK CREATINE KINASE RESULTS FROM COBAS 6000 C 501 MODULE SERIAL NUMBER (B)(4) DUE TO INTERFERENCE. SAMPLE 1 INITIAL RESULT WAS 500 U/L. THE REPEAT RESULT WITH A DILUTION WAS >57000 U/L. AS THIS DID NOT MATCH THE CLINICAL PICTURE FOR THE PATIENT, A NEW SAMPLE WAS DRAWN. SAMPLE 2 INITIAL RESULT WAS 7 U/L WITH A DATA FLAG. THE REPEAT RESULT WITH A REDUCED SAMPLE VOLUME WAS 47072 U/L WITH A DATA FLAG. ON ANOTHER ANALYZER, THE INITIAL RESULT WAS 1339 U/L WITH A DATA FLAG. THE REPEAT RESULT WITH A REDUCED SAMPLE VOLUME WAS 46386 U/L WITH A DATA FLAG. ADDITIONAL RESULTS FROM (B)(6) 2022 OF 1222 U/L WITH A DATA FLAG AND 46255 U/L WERE PROVIDED. FROM (B)(6) 2022, RESULTS OF 2971 U/L WITH A DATA FLAG AND 32794 U/L WERE PROVIDED. IT IS UNCLEAR FROM WHICH SAMPLE THESE RESULTS WERE GENERATED. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070073 ↗

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