Alerta De Seguridad para ORTHO VISION Analyzer ORTHO VISION analyzer Technical name: General biochemistry, hormone, drug or protein analysis instrument ANVISA registration number: 80145901739 Hazard class: II Affected model: ORTHO VISION Analyzer Affected serial numbers: All SKU equipment 6904579, with software versions 3.6.0 and earlier

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.

Some instructions are recommended: • After adjusting the incubation time parameters of a UDP test, the client must make sure to restart the system before processing the samples so that the incubation time parameters will be reset to the values ​​of the Assay Data Disk (ADD) for the Ortho test model and the associated UDPs will be reset to the original parameters validated during the analyzer reset. • Place this notification on your ORTHO VISION Analyzer or along with the user documentation. • Complete and return the Receipt Confirmation form