Calibrator for automated systems USA standardized 10759350360Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630936342), received between Oct 30, 2024 and Oct 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “High 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.

• MalfunctionOct 30, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE JAFFÉ GEN. 2 RESULTS FOR APPROXIMATELY 8 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS ANALYZER. THE CUSTOMER PROVIDED 3 EXAMPLES. PATIENT 1: THE INITIAL RESULT WAS 2.9 MG/DL AND THE REPEATED RESULT WAS 1.08 MG/DL. PATIENT 2: THE INITIAL RESULT WAS 3.1 MG/DL AND THE REPEATED RESULT WAS 0.86 MG/DL. PATIENT 3: THE INITIAL RESULT WAS 3.1 MG/DL AND THE REPEATED RESULT WAS 0.82 MG/DL. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE REPEATED BECAUSE CALIBRATION AND QC FAILED. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569432 ↗