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AU OSR6111Recalls & reported problems

Beckman Coulter, Inc. · Direct Bilirubin · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590010102), received between May 15, 2021 and May 15, 2021 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • High Test Results1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryMay 15, 2021High Test Results; High Test Results

    THE CUSTOMER REPORTED RECEIVING ERRONEOUS HIGH PATIENT RESULTS FOR DIRECT BILIRUBIN (DBIL) ON THE AU480 CLINICAL CHEMISTRY ANALYZER FOR NEONATAL SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. THERE WAS A REPORT OF A CHANGE TO PATIENT TREATMENT. PATIENTS HAD A PROLONGED HOSPITAL STAY WITH ADDITIONAL FOLLOW UP TESTING/MONITORING. IT IS UNKNOWN IF ADDITIONAL TREATMENT WAS RECEIVED.

    Patient problems: Insufficient Information

    MAUDE report 11830081 ↗

Other Diazo Colorimetry, Bilirubin devices

All Diazo Colorimetry, Bilirubin devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.