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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 Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above... 3 07/08/2016 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 5,1 FS 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 4600 Chemistry System, clinical chemistry analyzer 2 08/06/2019 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
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
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
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