Events

Safety Alert for Model LKIE 5 160 (500 tests / kit)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Diagnostic Products Corp.

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
    402
  • Date
    2002-02-22
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    In the above test kits, components, the beads (bead components), may be missing, resulting from improper packaging. the manufacturer initiated a removal by letter dated 31 october 2001.
  • Action
    Verify that you received the letter dated 31 October 2001 from Diagnostic Products. Identify and isolate any affected product in your inventory. For more information, contact Diagnostic Products by phone at (1310) 645-8200, or contact your local representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Model LKIE 5 160 (500 tests / kit)

Manufacturer

Diagnostic Products Corp
  • Source
    ANVSANVISA