Name of products: Calibrator Kit 29 Vitros *, RegANVISA 80145900910. Product classified as II and the control of these systems is carried out by lot number. 89 units of the reagent kit were imported. Product code 6802344, Lots affected and imported into Brazil: 2915, 2995 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.

If you have any questions regarding this field action, please contact Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. by telephone: 12 3932-7977 or e-mail: gbuosi@its.jnj.com Recommendations to users: Action required for laboratories that have the affected lot: • As soon as available, install ADD DRV 5884 or later on your system VITROS. o Connected Systems: Automatic download will be available in early May 2016. o ADD DRV 5884 or later will also be sent to your facility upon availability. NOTE: After loading ADD DRV 5884 or later for the first time, the VITROS dTIBC GEN 30 Reagent will lose the calibration and must be recalibrated. • After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory of the VITROS dTIBC, GEN 30 Reagent. • Place this notification on your VITROS System or along with your user documentation. • Complete and return the Receipt Confirmation form