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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 22 Results
510(K) Number: K031924
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VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1... 3 01/20/2015 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry Syst... 2 08/01/2014 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375... 2 06/09/2014 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use. 2 06/09/2014 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product ... 2 07/02/2013 FEI # 1000136573
Ortho-Clinical Diagnostics
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refu... 2 07/02/2013 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended... 2 04/13/2013 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished,... 2 04/13/2013 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, a... 2 07/23/2012 FEI # 1000136573
Ortho-Clinical Diagnostics
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and quali... 2 07/23/2012 FEI # 1000136573
Ortho-Clinical Diagnostics
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