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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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Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trad... 2 04/25/2015 Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- O... 2 01/14/2015 Ortho-Clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics. ... 2 01/14/2015 Ortho-Clinical Diagnostics
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For us... 2 01/14/2015 Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. T... 2 10/16/2014 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
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro ... 2 06/10/2014 Ortho-Clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measure... 2 06/09/2014 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 (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM... 2 06/02/2014 Ortho-Clinical Diagnostics
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