9 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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 Recall
Open, Classified
·Beckman Coulter, Inc.·Product code GIF·November 10, 2025
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 Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code GGK·May 25, 2022
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code GIF·May 31, 2023
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code GKZ·August 13, 2025
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code GKZ·August 13, 2025
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code GKZ·August 13, 2025
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code GKZ·August 13, 2025
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
FDA Recall
Open, Classified
·GE Medical Systems China Co., Ltd.
No. 19 Changjiang Road
Development Zone National Hi-Tech Xin District
Wuxi China·Product code DXH·April 21, 2026
React Health PHOENIX 5L Oxygen Concentrator
FDA Recall
Open, Classified
·3B Medical, Inc.
5475 Rings Rd Ste 550
Dublin OH 43017-7537·Product code CAW·February 4, 2026