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Beckman Coulter Ireland, Inc. FDA Recalls
3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol fClass IIDec 8, 2025Beckman Coulter identified that LDL Cholesterol OSR6x96 is n |
| BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitatClass IIOct 14, 2025Bicarbonate reagent may generate falsely high Bicarbonate re |
| Apo B Reagent, REF: OSR6143Class IIIApr 23, 2025The product Value Assignment Sheet (VAS) is used in calibrat |