Events

Safety Alert for Reagents, microbiology, control. Control sera for laboratory test kits for venereal disease research. catalog number 235201; Number of lots: 149027LA, 149484LA

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

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
    321
  • Date
    2001-11-02
  • 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
    Sera from weakly reactive controls from venereal disease research laboratories (vdrl) demonstrated comparable reactivity to, or stronger than, vdrl positive control sera. the exacerbated and unexpected reactivity of this control invalidates the assay and the user can not qualify the antigen suspension. the manufacturer commenced removal by letter dated june 2001.
  • Action
    Verify receipt of a letter dated June 2001 from BD Diagnostic Systems. Identify and isolate all affected products in your inventory. For more information, please contact your local representative. 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

Reagents, microbiology, control. Control sera for laboratory test kits for venereal disease resea...

Manufacturer

BD Diagnostic Systems
  • Source
    ANVSANVISA