Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Device Recalls
  • Print
  • Share
  • E-mail
-
1 to 10 of 35 Results
510(K) Number: K063144
 
 1 
 2 
 3 
 4 
 > 
Results per Page
New Searchexport reports to excelExport to Excel | HelpHelp
Product Description
Sort by Product Name [A-Z]
Sort by Product Name [Z-A]
Recall
Class
Sort by Recall Class [0-9]
Sort by Recall Class [9-0]
FDA Recall
Posting Date
Sort by Date Classified [0-9]
Sort by Date Classified [9-0]
Recalling Firm
Sort by Recalling Firm [A-Z]
Sort by Recalling Firm [Z-A]
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above... 3 07/08/2016 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 5,1 FS Chemistry System, clinical chemistry analyzer 2 08/06/2019 Ortho Clinical Diagnostics
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer 2 08/06/2019 Ortho Clinical Diagnostics
VITROS 4600 Chemistry System, clinical chemistry analyzer 2 08/06/2019 Ortho Clinical Diagnostics
VITROS 4600 Chemistry System, clinical chemistry analyzer 2 08/06/2019 Ortho Clinical Diagnostics
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measure... 2 12/20/2018 Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measure... 2 12/20/2018 Ortho-Clinical Diagnostics
enGen Track System with TCAutomation Software Version 4.2 2 12/14/2017 Ortho-Clinical Diagnostics
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut... 2 05/12/2017 Ortho-Clinical Diagnostics
-
-