7 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES (0.5L/KT) Catalog # B36868
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·February 11, 2026
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·July 19, 2023
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·September 24, 2025