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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 25 Results
510(K) Number: K060256
 
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Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay ... 2 03/15/2023 Beckman Coulter, Inc.
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used... 3 01/03/2018 Beckman Coulter Inc.
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems T... 2 07/22/2016 Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No.... 2 11/06/2014 Beckman Coulter Inc.
UniCel DxC 600i Synchron Access Clinical System; P/N 107405S Product Usage: The Access Immunoass... 2 04/01/2013 Beckman Coulter Inc.
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel ... 2 12/22/2012 Beckman Coulter Inc.
UniCel® DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel® DxC Synchron® Clinica... 2 10/24/2012 Beckman Coulter Inc.
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel D... 2 10/12/2012 Beckman Coulter Inc.
Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. ... 2 04/06/2012 Beckman Coulter Inc.
UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integrated Wo... 2 07/11/2011 Beckman Coulter Inc.
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