Safety Alert for VITROS * FOR PHENITOIN PHYT Technical Name: PHENYTOIN ANVISA Registration Number: 10132590219 Hazard Class: II Affected Model: VITROS * DRY REACTIVE FOR PHYTENIN PHENITOIN 5 cartridges with 18 slides VITROS Chemistry Products PHYT Slides , product code 8298671, lots: 1401566241, 1401566904, 1401577639, 1401578552, 1401578552, 1401580410, 1401589627, 1401591230, 1401592935, 1401604105 and 1401614738. The Assay Data Diskette (ADD) and Calibration 16607 products are not applicable.

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: 1) Install the Calibration Diskette / ADD DRV 5910 or later diskette in the system: The automatic download will be available for the e-Connected systems as of December 2, 2016; The Calibration Diskette and / or ADD diskette will also be sent to your installation upon availability. IMPORTANT NOTE: After charging the DRV 5910 (or later) for the first time, VITROS PHYT Slides will lose calibration and recalibrate. In the meantime, it is acceptable to continue using the product. 2) After successful calibration and quality control evaluation, it is acceptable to use existing inventory of VITROS PHYT Slides. 3) Place this notification on the VITROS System or along with the user documentation. 4) Fill out and return the Receipt Confirmation Form.