FDAJanuary 29, 2020device
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determination of carbon dioxide in human serum or plasma.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Electrolyte reference reagent, used for clinical laboratory testing to determine CO2 in human serum or plasma for diagnosis and treatment of potentially serious disorders associated with changes in the body acid-base balance, has a low pH and may cause CO2 calibration failures, high CO2 quality control recoveries, and false high patient results which can lead to delay in treatment.
What to do
FDA enforcement status: Terminated
Brands named
beckman coulterbeckman
UPCs
15099590202491
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAccess Total T4 Calibrator, Catalog No. 338052026-03-16
- FDACHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B232812026-01-30
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- FDACellMek SPS Sample Preparation System, REF: C44603, with software2025-12-23
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- FDABeckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit2025-11-26
- FDABeckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit2025-11-26
- FDACOULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemake...2025-11-10
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