Events

Alerte De Sécurité sur DRY REACTIVES VITROS * FOR PHBR, Registration No. 10132590518, lot: 2538-0060-7597 and lot: 2540-0063-4175

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1247
  • Date
    2013-04-01
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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
  • Cause
    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