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Beckman Coulter Ireland, Inc.

3 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique deter recall (Z-1135-2026)Beckman Coulter Ireland, Inc.2026-01-21
BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system r recall (Z-0997-2026)Beckman Coulter Ireland, Inc.2025-12-23
Apo B Reagent, REF: OSR6143 recall (Z-1815-2025)Beckman Coulter Ireland, Inc.2025-05-23

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Every clearance here is in the API, with alerts when new ones post.