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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 35 Results
510(K) Number: K042291
 
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Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 6... 1 03/04/2010 Beckman Coulter Inc.
Beckman Coulter UniCel DxI 600 Access Immunoassay System with Unicel DXI system software version 4.3... 2 06/28/2011 Beckman Coulter Inc.
GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part... 2 03/09/2011 Beckman Coulter Inc.
GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX... 2 09/09/2010 Beckman Coulter Inc.
ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are int... 2 05/28/2020 Beckman Coulter Inc.
Tubing Assembly #142, V2, V12 Mixer/Wash a component of the DxC instruments. Tube, Assembly, #14... 2 06/23/2011 Beckman Coulter Inc.
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access F... 2 06/09/2014 Beckman Coulter Inc.
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative,... 2 09/23/2014 Beckman Coulter Inc.
UniCel DxC 600 PRO Part Number: A10400, Beckman Coulter, Inc. 2 05/24/2008 Beckman Coulter Inc
UniCel DxC 600 Part Number: A10405, Beckman Coulter, Inc. 2 05/24/2008 Beckman Coulter Inc
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