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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 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343... 2 01/13/2016 Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 107587500011... 2 01/13/2016 Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343... 2 03/08/2016 Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 107587500011... 2 03/08/2016 Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 1... 2 04/26/2016 Ortho-Clinical Diagnostics
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 (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 Track System with TCAutomation Software Version 4.2 2 12/14/2017 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
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