Events

Alerte De Sécurité sur Biocheck Strip Bioeasy. Anvisa Registration Number 10374660079. Class of risk - Class IIIa

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 Bioeasy Diagnóstica 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
    892
  • Date
    2007-05-29
  • 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 carried out the replacement of some units of lot TD07A230-B03 after receiving a health service notification regarding the divergence of information between the code number and CODE number. The notification was also forwarded to ANVISA, through NOTIVISA, with the error identified: - CODE 1409 in the primary packaging and in the code strip 1973; - CODE 1409 in the primary packaging and the code strip 1410. After being questioned by Anvisa, the company informed that there was a failure in the packaging system, which enabled a Chip Code package with 12 units to be released with a different identifier number of the product packaging. According to the company, the imported quantity of this lot was 350 boxes, all of them being sold with a single distributor.
  • Cause
    Inconsistent with the code information of the primary packaging and the strip-code.
  • Action
    Bioeasy Diagnostica Ltda reported that the problem was isolated and restricted to only one customer. Units with bypass have been replaced.

Device

Biocheck Strip Bioeasy. Anvisa Registration Number 10374660079. Class of risk - Class IIIa

Manufacturer

Bioeasy Diagnóstica Ltda
  • Source
    ANVSANVISA