Creatine Kinase 08057460190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613336121122), received between Apr 11, 2026 and Apr 11, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

1 other recall cover devices cleared under the same FDA submission (K160570); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160570. One submission often covers many models, so check the product and lot details in each record.

• Z-3187-2024 · Aug 15, 2024 · Open, Classified
  Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Cata