Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL LTDA.; Abbott laboratories Diagnostics Division..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1583
  • Date
    2015-05-13
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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