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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 28 Results
510(K) Number: K031924
 
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VITROS® 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS® Chem... 2 08/16/2007 Ortho-Clinical Diagnostics
VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: Fo... 2 04/26/2012 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 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics. For us... 2 01/14/2015 Ortho-Clinical Diagnostics
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and quali... 2 07/23/2012 Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished,... 2 04/13/2013 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
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10... 2 09/02/2015 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
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