Company:Medimaps Group Date of Enforcement Report 11/16/2016 Class lI: PRODUCT TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.. Recall Number Z-0369-2017 REASON The FRAX adjusted for TBS values are not correct when: The FRAX feature is...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report 11/16/2016 Class lI: PRODUCT Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer...Read More