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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 22 Results
510(K) Number: K922823
 
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Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used... 2 10/11/2018 Beckman Coulter Inc.
Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 a... 2 03/15/2017 Beckman Coulter Inc.
Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access ... 2 03/15/2017 Beckman Coulter Inc.
UniCel DxC 600i SYNCHRON Access Clinical System, Part No. A25637, A25638 Product Usage: The Acce... 2 03/15/2017 Beckman Coulter Inc.
Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic ... 2 02/16/2014 Beckman Coulter Inc.
Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro dia... 2 11/14/2013 Beckman Coulter Inc.
Access 2 Immunoassay System; P/N 107405S 2/12 The Access Immunoassay Systems are in vitro diagnos... 2 04/01/2013 Beckman Coulter Inc.
Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in ... 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.
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access. Part Number: A... 2 04/06/2012 Beckman Coulter Inc.
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