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FDAOctober 14, 2025device

BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

beckman coulter irelandbeckmanbeckman coulter

UPCs

150995900201871509959001034815099590060206

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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