AU OSR6237Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590020187), received between Mar 18, 2026 and Mar 18, 2026 — classified as 1 injury.

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

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K131546); they may or may not involve this specific model.

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.

Recalls naming this device

1. Oct 14, 2025Open, Classified

   Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

   Z-0997-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Apr 5, 2023Open, Classified

   There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

   Z-1606-2023 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryMar 18, 2026High Test Results

  THIS EVENT WAS INITIALLY REPORTED UNDER MDR 9612296-2025-00950. FOLLOWING A REVIEW COMPLETED ON FEBRUARY 20, 2026, IT WAS DETERMINED THAT THIS EVENT SHOULD BE REPORTED UNDER THE REAGENT, RATHER THAN THE ANALYZER. ON (B)(6) 2025, IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE ERRONEOUSLY HIGH CARBON DIOXIDE (CO2) PATIENT RESULTS WHILE USING THE DXC 700 AU CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THAT THE CO2 RESULTS FROM THE ARTERIAL BLOOD GAS WERE "SIGNIFICANTLY DIFFERENT" THAN THE TOTAL CO2 MEASURED ON THE BECKMAN COULTER DXC 700 AU ANALYZER. THE CUSTOMER ALSO INDICATED THAT THE PATIENT WAS "VERY SICK" WITH MULTIPLE MORBIDITIES. PER THE CUSTOMER, THE PATIENT WAS SUSPECTED TO HAVE HIGH LACTATE DEHYDROGENASE (LDH) AND LACTATE (LAC) RESULTS. THE CUSTOMER REPORTED A POSSIBLE DELAY IN CHANGING THE DOSAGE OF CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) DUE TO THE ERRONEOUSLY HIGH CO2 RESULTS. THE CUSTOMER REPORTED THE PATIENT PASSED AWAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24635522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131546. One submission often covers many models, so check the product and lot details in each record.

• Z-1607-2023 · Apr 5, 2023 · Open, Classified
  Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL
• Z-1608-2023 · Apr 5, 2023 · Open, Classified
  Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL