Beckman Coulter Ireland, Inc.
Beckman Coulter Ireland, Inc. holds FDA 510(k) medical device clearances, first cleared 2013, most recent 2019, with 3 FDA device recalls on record.
Top product codes for Beckman Coulter Ireland, Inc.
FDA recalls by Beckman Coulter Ireland, Inc.
- Z-1135-2026 — 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.
- Z-0997-2026 — 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.
- Z-1815-2025 — Apo B Reagent, REF: OSR6143
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Beckman Coulter Ireland, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.