Events

Safety Alert for VISIT PREGNANCY. Anvisa Registry No. 10350840127. Products under risk in Brazil: Lot 13052 (expiry 01/31/2015), lot 13053 (expiry 01/31/2015) and lot 13057 (expiry 05/31/2015).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOSYS LTDA; OMEGA DIAGNOSTICS LTDA.

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
    1300
  • Date
    2013-10-03
  • 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 is collecting batches at risk due to complaints received, related to obtaining false-positive results with the product in question. The retention samples in the manufacturer did not show the deviation, however the company is preventively collecting the product and is investigating the cause of the problem. Access to the Company Alert Message: http://portal.anvisa.gov.br/wps/wcm/connect/362e3b004152ff89a58fafa8d08ea2d4/Carta_de_Recall_aos_clientes.pdf?MOD=AJPERES
  • Reason
    Possibility of occurrence of false-positive results higher than expected for the product.
  • Action
    Lots under risk will be collected by the registry holder. Identify and segregate the products at risk in your inventory and contact Biosys Ltda for return.

Device

VISIT PREGNANCY. Anvisa Registry No. 10350840127. Products under risk in Brazil: Lot 13052 (expir...

Manufacturer

BIOSYS LTDA; OMEGA DIAGNOSTICS LTDA
  • Source
    ANVSANVISA