Events

Safety Alert for OPTIUM XCEED DIABETES CONTROL SYSTEM. OPTIUM XCEED DIABETES CONTROL SYSTEM.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL 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
    911
  • Date
    2008-04-25
  • 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
    This alert is intended to clarify the correct use of the products described above, being applicable to all lot numbers thereof. The use of the OPTIUM and OPTIUM XCEED diabetes control systems when used with their specific test strips are guaranteed by the manufacturer.
  • Reason
    If you are using the test strips of johnson & johnson co (one-touch glucose monitoring strips) on the monitors of the optium and optium xceed diabetes monitoring systems (abbott laboratories ltda. or any other strip not recommended by aboott, your results may be lower than expected.
  • Action
    Use only the glucose monitoring strips specific to the OPTIUM and OPTIUM XCEED diabetes control systems, as described in the user manual for these products.

Device

OPTIUM XCEED DIABETES CONTROL SYSTEM. OPTIUM XCEED DIABETES CONTROL SYSTEM.

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA