Alerta De Seguridad para ENGEN LABORATORY AUTOMATION SYSTEM ENGEN LABORATORY AUTOMATION SYSTEM ANVISA Registration Number: 80145901089 Hazard Class: I Affected Model: ENGEN LABORATORY AUTOMATION SYSTEM Affected Batch / Serial Numbers: Series - Engen

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.

A Tag Read fault in the VITROS Bypass suction position (STOPPER_DEVIATOR) is one of the events required for this problem to occur. Tag Read failures are not common and indicate that Sample ID information for the sample can not be read. To identify a Tag Read Fault event that may indicate that the problem has occurred, do the following: • On the TCA controller, check the "Show All Messages" screen (Select MessagesMMore¿ Show All Messages ) to see if the Error ID 525 associated with the VITROS System message and the Workstation Error Details message showing "STOPPER_DEVIATOR" appears. (See "Error Illustrations 525" on Page 3). Ortho recommends that this check be performed at least during daily maintenance. • If you only identify an Error ID 525 associated with a VITROS System and Workstation Error Details showing "STOPPER_DEVIATOR": o Contact the Ortho Care ™ Technical Support Center immediately for assistance in determining whether the problem it occurred. NOTE: Ortho has a limited ability to determine if the problem occurred on your system before the date of the oldest backup file on the system (the default is 30 days). Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action. o Until instructed otherwise by Ortho Care, do not put samples on the rail for sorting or routing. Place the samples directly into the analyzer. • Complete and return the Receipt Confirmation form.