Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1971
  • Date
    2016-07-29
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    The coaguchek xs pt test strips product, 6 units, code 04625374190, was supplied without the accompanying instructions for use in english.
  • Action
    Field Action No. RDB_2016_001 triggered under the responsibility of Roche Diagnóstica Brasil. Correction of Instructions for Use - Requires Alert Message on large circulation media.

Device

Trade name: COAGUCHEK XS PT TESTSTRIPS 6 tests //. Technical name: SELF-TEST FOR COAGULATION PARA...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH