Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 10/22/2014 Class lI: PRODUCT VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Recall Number Z-0078-2015 REASON...Read More

Company:Ortho-Clinical DiagnosticsDate of Enforcement Report: 10/22/2014 Class lI: PRODUCT VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate,...Read More

Company:Merge Healthcare, Inc.Date of Enforcement Report: 10/22/2014 Class lI: PRODUCT eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources...Read More