Events

Safety Alert for Commercial Name: PROBE SAMPLE Technical Name: Sample Probe ANVISA Registration Number: 80145240438 Model Affected: PROBE SAMPLE; PROBE SAMPLE S; SAMPLE PROBE

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

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
    2255
  • Date
    2017-03-31
  • 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
    Roche Diagnóstica Brasil will shortly announce its clients affected by this issue. Roche Diagnostica Brasil is organizing a schedule of evaluation visits and / or requesting information from the equipment involved in this action to its clients to identify potentially affected sample probes and to exchange the probe, if necessary. For questions and support, please contact the CEAC Service Center - 08007720295 of Roche Diagnóstica Brasil Ltda. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    Roche diagnostica brasil has been informed by its manufacturer roche diagnostics gmbh that in very rare cases a disturbance in the detection of sample liquid level (lld) may occur due to the friction corrosion of the sample probe connector as a result of a change in production of this connector.
  • Action
    Field Action Code SBN-CPS-2017-005 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make correction in the field.

Device

Commercial Name: PROBE SAMPLE Technical Name: Sample Probe ANVISA Registration Number: 8014524043...

Manufacturer

Roche Diagnóstica Brasil Ltda; Hitachi High-Technologies Corporation
  • Source
    ANVSANVISA