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AU OSR6112Recalls & reported problems

Beckman Coulter, Inc. · Total Bilirubin · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590010119), received between May 7, 2018 and May 7, 2018 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Low Test Results1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMay 7, 2018Low Test Results; Low Test Results

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW PATIENT RESULTS FOR TOTAL BILIRUBIN (TBIL) INVOLVING THE AU680 CLINICAL CHEMISTRY ANALYZER. THE LOW RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. QUALITY CONTROL WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES PRIOR TO THE GENERATION OF THE LOW RESULTS. THERE WAS NO CHANGE TO PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7491944 ↗

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.