AU OSR6222Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590020118), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryApr 8, 2020Low Test Results; Low Test Results

  ON 28-FEBRUARY-2020, THE CUSTOMER REPORTED THE GENERATION OF FALSE LOW PHOSPHORUS RESULT FOR ONE (1) PATIENT ON THE AU5800 CLINICAL CHEMISTRY ANALYZER. THE DOCTOR QUESTIONED THE PATIENT RESULTS AS THEY DID NOT MATCH THE PATIENT CLINICAL PRESENTATION. THE PATIENT HAD BEEN TREATED WITH AN IV ADMINISTRATION OF AMPHOTERICIN B LIPOSOMAL AT 65 MG ADMINISTERED OVER 120 MINS PRIOR TO THE BLOOD DRAW. LIPOSOMAL AMPHOTERICIN-B (L-AMB) IS A FORMULATION OF AMPHOTERICIN B THAT HAS BEEN EMBEDDED IN A UNILAMELLAR PHOSPHOLIPID BILAYER. THIS SPECIFIC FORMULATION IS LESS TOXIC AND HAS BEEN APPROVED FOR INVASIVE ASPERGILLUS, CANDIDA, AND CRYPTOCOCCUS INFECTIONS AT DOSAGES FROM 3 TO 6 MG/KG/DAY. ON 01-APRIL-2020, THE CUSTOMER NOTIFIED BECKMAN COULTER THAT THE PATIENT WAS ADMINISTERED POTASSIUM PHOSPHATE TO REMEDIATE THE ¿LOW¿ PHOSPHORUS LEVELS. A SELECTION OF SAMPLES FROM THE SAME PATIENT WERE SENT TO ANOTHER LABORATORY TO CONFIRM THE RESULTS. THE SAMPLES WERE TESTED USING THE ABBOTT ARCHITECT AND SOME RESULTS WERE FOUND DISCREPANT. THE VARIABILITY IN RESULTS MAY BE EXPLAINED BY THE ADMINISTRATION OF POTASSIUM PHOSPHATE TO REMEDIATE THE ¿LOW¿ PHOSPHORUS LEVELS.

  Patient problems: No Information

  MAUDE report 9940986 ↗