Product name: Thyroxine (T4) ### Registration number ANVISA: 10132590400 ### Hazard class: II ### Product code: 8744468 ## Trademark: IMMUNODIAGNOSTIC REAGENT KIT VITROS * ECi FOR TOTAL T4 ### Technical Name: # Batch numbers affected: 1845; 1880; 1900; 1930; 1950 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.

Action required for laboratories that have the affected lot: • VITROS TT4 Reagent Kits (listed above and future lots 2008 and later) should only be used within 4 weeks of opening. Manually track the time interval for storing the reagent kits opened for Batches prior to 2008. • The VITROS TT4 Instructions for Use (IFU) will be updated to reflect this change. The revised Instructions for Use (IFU) will be available on our website at http://www.orthoclinical.com, when the next batch is released, which is expected to begin in June 2016. In the meantime, please keep this notification to checking the change in the storage requirement of open reagent kits. • In accordance with regulatory requirements, complete and return the Receipt Confirmation. • This is a situation in which the use of the product is not likely to cause adverse health consequences. • Incorrect value may cause undue results. The Laboratory Medical Officer should be consulted about any questions you may have regarding previously reported TT4 results to determine the appropriate course of action. The results of this or other diagnostic test should be used and interpreted only within the context of the general clinical picture. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link