ADVIA Chemistry Creatine Kinase 10729780Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414008943), received between Dec 25, 2025 and Dec 25, 2025 — classified as 1 malfunction.

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

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

• MalfunctionDec 25, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED CREATINE KINASE (CK_L) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2400 CHEMISTRY INSTRUMENT. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS AUTO REPEATED ON THE ORIGINAL INSTRUMENT. THE AUTO REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CK_L RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891963 ↗