120 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·January 2, 2013
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·April 10, 2013
Access Immunoassay Systems Reaction Vessels. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·December 25, 2013
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. Part Number: A54376, Synchron LXi 725 APF, Part Number: A54377, Synchron LXi 725 AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·September 11, 2008
Access 2 immunoassay side of LXi 725
FDA Recall
Terminated
·Beckman Coulter Inc·January 30, 2003
HiSpeed LXI (2200997)
FDA Recall
Terminated
·GE Healthcare, LLC·Product code JAK·February 1, 2010
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·November 1, 2012
SYNCHRON LXi 725 System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JGS·April 3, 2008
Synchron LXi 725, Part Number A08357, Beckman Coulter, Inc.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 5, 2007
Access Power Supply Assembly Sled Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·October 17, 2007
SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part Number: A23724
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·March 15, 2006
Synchron LX I 725 The Synchron LXi 725 System combines the Synchron LX20 PRO analyzer and the Access 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquotter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or LX20 PRO analyzer according to programming requirements.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JGS·October 22, 2010
Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JQP·September 18, 2003
Access 2 Immunoassay System
FDA Recall
Terminated
·Beckman Coulter Inc·January 30, 2003
Synchron LXi 725, Part Number: 476501. Designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·April 5, 2011
Access Immunoassay Systems Assay Protocol: Dil-AFP.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code LOJ·July 18, 2005
SYNCHRON LxI 725 Access Clinical Systems, Part Number: 386200. An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·October 5, 2010
Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IXR·October 21, 2004
Synchron LXi 725 Clinical System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·February 12, 2013
Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
FDA Recall
Terminated
·Sunrise Medical Inc·Product code IOR·February 2, 2009