Events

Safety Alert for DRY REACTIVES VITROS * FOR PHBR, Registration No. 10132590518, lot: 2538-0060-7597 and lot: 2540-0063-4175

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

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
    1247
  • Date
    2013-04-01
  • 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
    According to the company's statement, the manufacturer considers that it is a situation in which the use or exposure to the affected product may cause adverse or reversible adverse health consequences or where the likelihood of serious adverse health consequences is remote. If in doubt, the company requests that you contact the Technical Services to the Customer at 0800-728-7865 or 11 9 8223. See Customer Letter at: http://portal.anvisa.gov.br/wps/ content / Anvisa + Portal / Anvisa / Reports + Tecnicos / Menu + - + Alerts + and + Reports / Alerts + de + Tecnovigilancia
  • Reason
    The manufacturer company has identified in research that positive bias values ​​for patient samples, which may have been obtained, could not be detected by quality control fluids.
  • Action
    The company that registers in Brazil is collecting the product and advises that: i) Discontinue use and discard all VITROS PHBR Slides remaining in your inventory; ii) Complete and return the Receipt Confirmation form (attachment); iii) Send this notification to all laboratories in your facility that use VITROS PHBR Slides; iv) Place this notification next to each VITROS System using the VITROS PHBR Slides or together with your VITROS user documentation.

Device

DRY REACTIVES VITROS * FOR PHBR, Registration No. 10132590518, lot: 2538-0060-7597 and lot: 2540-...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda