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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 4600 Chemistry System, clinical chemistry analyzer 2 08/06/2019 Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer 2 08/06/2019 Ortho Clinical Diagnostics
VITROS 4600 Chemistry System, clinical chemistry analyzer 2 08/06/2019 Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer 2 08/06/2019 Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measure... 2 12/20/2018 Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measure... 2 12/20/2018 Ortho-Clinical Diagnostics
enGen Track System with TCAutomation Software Version 4.2 2 12/14/2017 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
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 1... 2 04/26/2016 Ortho-Clinical Diagnostics
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