Events

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

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

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
    1583
  • Date
    2015-05-13
  • 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
    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.
  • Cause
    Product or material with loose lids causing leakage during transport. the alkaline solution is corrosive and worker exposure may occur.
  • Action
    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.
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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