Company: Beckman Coulter Inc. Date of Enforcement Report 5/10/2017 Class lI: PRODUCT AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser,...Read More

Company: Roche Diabetes Care, Inc. Date of Enforcement Report 5/10/2017 Class lI: PRODUCT Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads...Read More