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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 35 Results
510(K) Number: K063144
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enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 1... 2 04/26/2016 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
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 01/13/2016 Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10... 2 11/05/2015 Ortho-Clinical Diagnostics
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445... 2 06/26/2015 Ortho-Clinical Diagnostics
Assay Data Disk (ADD), All DRV versions that support product within expiry dating Automates pre-a... 2 06/08/2015 Ortho-Clinical Diagnostics
enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the fo... 2 06/08/2015 Ortho-Clinical Diagnostics
Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trad... 2 04/25/2015 Ortho-Clinical Diagnostics
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