Alerta De Seguridad para Trade name: ID-DIAPANEL P Technical name: IMMUNOHEMATOLOGY - ENZYME HEMACY / HEMATELIC REAGENTS Registration number ANVISA: 80004040131 Hazard class: IV Model affected: 004214V Serial numbers affected: 45171.88.1

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.

* We recommend to immediately stop the use ONLY of test cells 1 of the kit "ID-DiaPanel-P", lot 45171.88.1 and "ID-DiaPanel", lot 45161.88.1. The other test cells (test red cells 2 to 11) are in compliance with the Quality Control criteria and should be used normally. * Identify and segregate boxes of products containing ONLY the test cells 1 of the "ID-DiaPanel-P" kit, lot 45171.88.1 and "ID-DiaPanel", lot 45161.88.1, to be returned to Bio-Rad. * Use the new test cells 1 (ID-DiaPanel-P 1, lot 05361.88.2 and ID-DiaPanel 1, lot 06171.88.2) and the new table of antigens received with the other test cells (2 to 11) of the kit "ID-DiaPanel-P", lot 45171.88.1 and "ID-DiaPanel", lot 45161.88.1.