Events

Alerte De Sécurité sur Slidex Rota-Kit 2

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 Biomerieux S/A Brasil.

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
    829
  • Date
    2006-04-24
  • 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 product is registered in Brazil under the nº 10158120201, valid until 19-12-2006. There are currently no notifications of technical complaints about the product involved in this Alert 829. The Technovigilance Unit is monitoring the actions taken by the company and warns of the importance of customers being aware of the problem and of notifying any technical complaints (technical surveillance @ anvisa.gov.br). The Technovigilance Unit was notified by the company on April 24, 2006. Biomérieux Brasil SA addressed a letter to the clients on 04-07-2006. UPDATE: 06-13-2006: 1.Company sent a letter to the UTVIG (received at Anvisa on 06-07-2006) informing that it has already collected all kits involved in the Alert. 2.The company was directed to seek the State Sanitary Surveillance Center / RJ to carry out the destruction according to the guidelines of the said Center. I look forward to returning information to update the Alert and terminate the notification. UPDATE: 01/22/2007: Company reported that the products were incinerated and that VISA RJ was informed of this procedure on 12/26/2006 by means of correspondence registered in said VISA on 12/27/2006. This notification is now closed.
  • Cause
    Biomérieux brasil sa communicated the decision of biomérieux brasil s / a to collect the lots 50608 (validity: august 10, 2006) through the national agency of sanitary surveillance (anvisa), through its utvig, and 50609 (validity: august 10, 2006) of the product slidex rota-kit 2. these batches have been shown to have, over time, a gradual loss of sensitivity of the latex r1 reagent, causing low agglutination of the r3 positive control, leading to possibility of false-positive results. this result does not cause an adverse event in the patient, however it does not allow the correct identification of the gastrointestinal agent and may lead to abusive prescription of antibiotics not indicated for the treatment of gastroenteritis of viral etiology. the company received a complaint from brazil, in addition to 13 other countries.
  • Action
    The Company Biomérieux Brasil SA informed its clients and started the voluntary withdrawal of the market of the unused lots involved in the problem and blocked the commercialization of these lots that are still in stock.

Device

Slidex Rota-Kit 2

Manufacturer

Biomerieux S/A Brasil
  • Source
    ANVSANVISA