Events

Alerta De Seguridad para HIV Test Bioeasy, Registration No. 10071770701, Lot 03AD15001-A

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ALERE S.A.; Standard Diagnostics.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1761
  • Fecha
    2015-12-01
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Alere SA imports the Bioeasy HIV test kit in individual packaging for repackaging in Brazil. Exclusively for supply to the Ministry of Health, the company uses a package in addition to the actual packaging of the kit, ie the kit comes in two boxes
  • Causa
    The company reported that a part of lot 03ad15001-a, hiv kit 03fk10 was provided with the wrong secondary box label. in the secondary packaging, the label was printed wrongly quoting the alere hcv 02fk10 kit and not the bioeasy 03fk10 hiv test kit. the label on the outer carton (shipping box), the inner carton and the individual packaging of the kit are correct.
  • Acción
    The company is performing the collection of the affected lot, I was distributed exclusively to the Ministry of Health.

Device

HIV Test Bioeasy, Registration No. 10071770701, Lot 03AD15001-A

Manufacturer

ALERE S.A.; Standard Diagnostics
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA