Events

Alerta De Seguridad para ALKALINE WASH, registration: 80146501155, hazard class: I, serial / lot number: 49059UN14.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Abbott laboratories Diagnostics Division..

¿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
    1583
  • Fecha
    2015-05-13
  • 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
    According to the company the solution contained in this product presents a potential chemical hazard because the alkaline solution is corrosive and the operator may be exposed when the bottle is leaking. According to the Material Safety Data Sheet, severe burns to the skin and mucous membranes may occur.
  • Causa
    Product or material with loose lids causing leakage during transport. the alkaline solution is corrosive and worker exposure may occur.
  • Acción
    The record holder will collect and destroy the product. The company asks customers to verify that Alkaline Wash, LN 9D31-20, lot 49059UN14 is in use or in stock. If yes, perform, using appropriate personal protective equipment (PPE), visual inspection in your inventory. If any signs of leakage or loose lids are observed, discontinue use immediately and segregate any remaining stock from these kits in accordance with your institution's policy and procedures for later recall. You DO NOT observe any signs of leakage or loose covers, you may continue to use the product following the precautions in the ARCHITECT System Operations Manual and Safety Data Sheet. For more information, see the attached Letter to the Client.

Device

ALKALINE WASH, registration: 80146501155, hazard class: I, serial / lot number: 49059UN14.

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Abbott laboratories Diagnostics Division.
  • 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