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U.S. Department of Health and Human Services

Medical Device Recalls
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21 to 30 of 35 Results
510(K) Number: K063144
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VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For us... 2 01/14/2015 Ortho-Clinical Diagnostics
VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1... 3 01/20/2015 Ortho-Clinical Diagnostics
VITROS&amp;amp;amp;amp;reg; 5,1 FS Refurbished System, Product Codes: 6801375 &amp;amp;amp;... 2 04/26/2012 Ortho-Clinical Diagnostics
VITROS&amp;amp;amp;amp;reg; 5,1 FS System, Product Codes: 6801375 &amp;amp;amp;amp;amp; 680... 2 04/26/2012 Ortho-Clinical Diagnostics
VITROS® 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS® Chem... 2 08/16/2007 Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro ... 2 06/10/2014 Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM... 2 06/02/2014 Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 1... 2 04/26/2016 Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut... 2 05/12/2017 Ortho-Clinical Diagnostics
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge... 2 10/22/2016 Ortho-Clinical Diagnostics
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