Events

Safety Alert for DIAGNOSTIC REAGENTS FOR USE IN VITRO VIDAS CHLAMYDIA / REF. 30101 ANVISA Registry No. 10158120169 - LOTS: 040212-0 E 040218-0

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

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
    732
  • Date
    2003-08-26
  • 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 a credit will be generated to the Laboratories, and that it has already begun the import process in emergency catater, once all the stock has been totally compromised due to the collection. If you received a letter dated August 26, 2003, complete the Return Certificate and return it by fax 21-2445.9523. For further information, please contact BIOMÉRIEUX BRASIL SA, by calling 0800 26 4848 - option 2, or your local representative.
  • Reason
    The process of decreasing the stability of a raw material that composes the reagents was detected, this fact could generate false negative results.
  • Action
    Issue of letter dated August 26, 2003 - Notice of Collection - requesting to suspend the use of lots and to retest all samples of negative results since July 24.

Device

DIAGNOSTIC REAGENTS FOR USE IN VITRO VIDAS CHLAMYDIA / REF. 30101 ANVISA Registry No. 10158120169...

Manufacturer

BIOMÉRIEUX BRASIL S.A
  • Source
    ANVSANVISA