Events

Safety Alert for Analyzers, laboratory, hematology, coagulation, Software for coagulation analyzer Behring Coagulation System Coagulation, model OV003, version 2.2

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Dade Behring Inc; Dade Behring GmbH.

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
    338
  • Date
    2001-11-16
  • 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
    The above software has a partially activated false-thromboplastin time period. the manufacturer initiated the correction by a letter dated 25 june 2001 from dade behring.
  • Action
    Check receipt of letter dated June 25, 2001 from Dade Behring. The company claims that representatives have updated customer data files. For more information, please contact your local representative. ANVISA is interested in following if there has been good collaboration of the manufacturer | your laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Analyzers, laboratory, hematology, coagulation, Software for coagulation analyzer Behring Coagula...

Manufacturer

Dade Behring Inc; Dade Behring GmbH
  • Source
    ANVSANVISA