Alerte De Sécurité sur Trade name: COAGUCHEK XS PT TESTSTRIPS 6 tests //. Technical name: SELF-TEST FOR COAGULATION PARAMETERS //. ANVISA registration number: 10287410553 //. Risk class: III (High Risk) //. Affected lots: 11911822; 20646321; 20335921; 23343322; 23194921; 23073621

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.

Actions to be taken by the user: Roche Diagnóstica invites the users of the product involved to contact the company to request a new box, duly accompanied by instructions for use in Portuguese. The user should contact Roche Diagnóstica, through the telephone 0800-772-0295, forwarding a copy of the invoice of the product purchased between 07/01/2015 and 08/10/2016. Within 10 business days, the user will receive the new product. The company is also available to answer any queries, by calling 0800-772-0295, or e-mail brasil.vozdocliente@roche.com -xxxxxxxxxxxxxxxxxxxxx-xxxxxxxxxxxxx- If you wish to notify technical complaints and adverse events, please use the channels below: Notivisa: Notices of adverse events (EA) 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 #### UPDATED ON 08/22/2017, the company sent a report of completion of the field action proving the sending and communication to customers regarding the misconception of the product shipment without the instructions for use.