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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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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 Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, ... 2 01/26/2012 Ortho-Clinical Diagnostics
VITROS® 5,1 FS System, Product Codes: 6801375 & 680... 2 04/26/2012 Ortho-Clinical Diagnostics
VITROS® 5,1 FS Refurbished System, Product Codes: 6801375 &... 2 04/26/2012 Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished,... 2 04/13/2013 Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM... 2 06/02/2014 Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375... 2 06/09/2014 Ortho-Clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measure... 2 06/09/2014 Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro ... 2 06/10/2014 Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry Syst... 2 08/01/2014 Ortho-Clinical Diagnostics
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