Events

Safety Alert for 16 VITER CALIBRATOR KIT. Registration Anvisa n ° 80145900790. Lot n ° 1630, expiration date 03/14/2012.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1103
  • Date
    2011-12-05
  • 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
    -
  • Reason
    Results from patients generated using the vitros rf reagent calibrated with the 16 vitros calibrator kit, lot # 1630, may show a positive (bias) trend in the measurement range of 8.6-120 iu / ml in case of a new calibration.
  • Action
    To users: (a) discontinue use and discard all products Calibrator Kit 16 VITROS, Lot 1630; (b) complete and return the attached Confirmation of Receipt form as soon as you receive this alert; (c) send this notice to all departments and areas using the 16 VITROS Calibrator Kit, Lot 1630. Place this notification in the vicinity of all VITROS Systems or VITROS Integrated Systems in your facility using the 16 VITROS Calibrator Kit, Lot 1630 , or together with the VITROS user documentation.

Device

16 VITER CALIBRATOR KIT. Registration Anvisa n ° 80145900790. Lot n ° 1630, expiration date 03/14...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.