Multiplate® Analyzer Technical Name: Haemostasis Analyzer Registration Number ANVISA: 10287411001 Hazard Class: I Affected Model: Serial Numbers Affected: List of Serial Number Distributed in Brazil and Potentially Affected: 100120; 100296; 100933; 101328; 101340; 101342; 101430; 101438; 101439; 101527; 101567; 101612. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

USER RECOMMENDATION: - If you are using the Multiplate® analyzer with software version 2.04, print only with A4 size paper in portrait (portrait) orientation. You can check which software version you are using by looking at the title bar of the Multiplate® software application (see the figure of the notification letter). - If you are using paper size other than A4, please do not use the feature to display the reference and target ranges in graphic format. This functionality should be disabled for each test parameter, using the "Edit Tests" window. To deactivate this feature, by test setup, follow the instructions described in the Operator's Manual (V2.0, SW 2.04, Chapter Operation / Configuration / Editing Test Parameters, page 128). - The form contained at the end of the notification must be completed and returned to Roche Diagnóstica Brasil.