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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 22 Results
510(K) Number: K063144
 
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enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, ... 2 01/26/2012 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS® 5,1 FS Refurbished System, Product Codes: 6801375 &... 2 04/26/2012 FEI # 1000305841
Ortho-Clinical Diagnostics
VITROS® 5,1 FS System, Product Codes: 6801375 & 680... 2 04/26/2012 FEI # 1000305841
Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM... 2 06/02/2014 FEI # 1000136573
Ortho-Clinical Diagnostics
enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measure... 2 06/09/2014 FEI # 1000136573
Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro ... 2 06/10/2014 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. T... 2 10/16/2014 FEI # 1000136573
Ortho-Clinical Diagnostics
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trad... 2 04/25/2015 FEI # 1000136573
Ortho-Clinical Diagnostics
enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the fo... 2 06/08/2015 FEI # 1000136573
Ortho-Clinical Diagnostics
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-a... 2 06/08/2015 FEI # 1000136573
Ortho-Clinical Diagnostics
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