Creatine Kinase 7190794190Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04015630940806), received between Jul 20, 2022 and Sep 22, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

1 FDA recall record name this device's 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, 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 16, 2026.

Recalls naming this device

1. Aug 15, 2024Class IIOpen, 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 problems

Recent adverse event reports

The 11 most recent of 11 reports, 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 ↗
• 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 ↗
• 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 ↗