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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 35 Results
510(K) Number: K063144
 
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enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, ... 2 01/26/2012 Ortho-Clinical Diagnostics
enGen Track System with TCAutomation Software Version 4.2 2 12/14/2017 Ortho-Clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measure... 2 06/09/2014 Ortho-Clinical Diagnostics
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above... 3 07/08/2016 Ortho-Clinical Diagnostics
enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the fo... 2 06/08/2015 Ortho-Clinical Diagnostics
enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge... 2 10/22/2016 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 (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 1... 2 04/26/2016 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 TCAutomation" Software v3.5 -- For in vitro ... 2 06/10/2014 Ortho-Clinical Diagnostics
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