Events

Alerta De Seguridad para Calibrators T4 Total Architect. Schedule 6C49-01; Lots # 71756Q100

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratories Health Products.

¿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
    468
  • Fecha
    2002-01-16
  • 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
    Informs that the Brazil unit of Abbott Laboratories received only 2 (two) Product Kits ARCHITECT T4 total Calibrator, Listing # 6C49-01; Lots # 71756Q100, and that none of the units have been sold, and are hitherto segregated in stock awaiting destruction, until an adequate volume of products has been accumulated to justify the incineration process.
  • Causa
    Calibrators when used to calibrate the t4 total architect assay show a trend of decreasing 9% in patient outcomes. the abbott total t4 lower controls and medium (m) controls also have the potential to identify lower label specifications (66-9229 / r1). the distributor started removal by letter dated august 20, 2001.
  • Acción
    Make sure you have received Abbott's letter dated August 20, 2001. Identify and isolate any affected product in your inventory. Destroy all material with the lot number above that you have in your laboratory or stocked at the facility according to laboratory procedures. If you have sent any affected product to another laboratory, please provide the lab, copy the Abbott letter. For more information, contact your local representative. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

Calibrators T4 Total Architect. Schedule 6C49-01; Lots # 71756Q100

Manufacturer

Abbott Laboratories Health Products
  • Source
    ANVSANVISA