Events

Alerte De Sécurité sur TREPANOSTIKA TP RECOMBINANT - Registration ANVISA nº 10158120502, Reference 285034 - Lots D37FA and D37FB, Reference 285035 - Lots D37FA and D37FB - Validity: 06/2007, 07/2007 and 08/2007

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 BIOMÉRIEUX BV.

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
    852
  • Date
    2007-01-10
  • 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
    The Company informs that after risk assessment, it reiterates that there is no sanitary impact, since in case of occurrence of the problem, the race is given with invalid. He also states that there was no question from the customers who purchased the product. For further clarification, please contact your local representative or the customer service department - Biomérieux 0800264848. The Company, through a file sent to UTVIG dated March 16, 2007, informs the closing of the collection.
  • Cause
    There is an increased risk that the absorbance of the negative control, whether very high - negative control is not within the qualification values, as described in the instructions for use.
  • Action
    The company informs that it is taking all steps to solve the problem and decided: 1 - Block the commercialization of the lots, 2 - Inform its clients the collection of lots by means of notification (letter).

Device

TREPANOSTIKA TP RECOMBINANT - Registration ANVISA nº 10158120502, Reference 285034 - Lots D37FA a...

Manufacturer

BIOMÉRIEUX BV
  • Source
    ANVSANVISA