3 results
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64ms
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Sources: EU EUDAMED, US FDA
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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.
FDA Recall
Open, Classified
·Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland·Product code KHS·October 14, 2025
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
FDA Recall
Open, Classified
·Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland·Product code LBS·December 8, 2025
Apo B Reagent, REF: OSR6143
FDA Recall
Open, Classified
·Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland·Product code JHN·April 23, 2025