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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 25 Results
510(K) Number: K060256
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Tubing Assembly #142, V2, V12 Mixer/Wash a component of the DxC instruments. Tube, Assembly, #14... 2 06/23/2011 Beckman Coulter Inc.
UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10... 2 04/13/2011 Beckman Coulter Inc.
UniCel DxC 600i Access Immunoassay Systems, Part Number A25656. An in vitro diagnostic device use... 2 04/12/2011 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.
Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; ... 2 12/13/2010 Beckman Coulter Inc.
UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9... 2 09/30/2010 Beckman Coulter Inc.
Closed Tube Aliquotter (CTA) for UniCel DxC 600i, Part Number: A25637, Domestic; A25633, Internatio... 2 09/20/2010 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.
Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell. PN Numbers: A10405 (UniCel DxC 6... 1 03/04/2010 Beckman Coulter Inc.
Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Acce... 2 03/02/2010 Beckman Coulter Inc.
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