Events

Safety Alert for TREPANOSTIKA TP RECOMBINANT - Registration ANVISA nº 10158120502, Reference 285034 - Lots D37FA and D37FB, Reference 285035 - Lots D37FA and D37FB - Validity: 06/2007, 07/2007 and 08/2007

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

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
    852
  • Date
    2007-01-10
  • 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
    The Company informs that after risk assessment, it reiterates that there is no sanitary impact, since in case of occurrence of the problem, the race is given with invalid. He also states that there was no question from the customers who purchased the product. For further clarification, please contact your local representative or the customer service department - Biomérieux 0800264848. The Company, through a file sent to UTVIG dated March 16, 2007, informs the closing of the collection.
  • Reason
    There is an increased risk that the absorbance of the negative control, whether very high - negative control is not within the qualification values, as described in the instructions for use.
  • Action
    The company informs that it is taking all steps to solve the problem and decided: 1 - Block the commercialization of the lots, 2 - Inform its clients the collection of lots by means of notification (letter).

Device

TREPANOSTIKA TP RECOMBINANT - Registration ANVISA nº 10158120502, Reference 285034 - Lots D37FA a...

Manufacturer

BIOMÉRIEUX BV
  • Source
    ANVSANVISA