Events

Safety Alert for Trade name: LIPASE RANDOX. Technical Name: LIPASE. ANVISA registration number: 80158990110. Risk class: II. Affected Model: LI3837, LI7979

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by RANDOX BRASIL LTDA; RANDOX LABORATORIES LTD.

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
    1931
  • Date
    2016-06-13
  • 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
    Follow manufacturer's guidelines (Attached) If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AEs) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System . To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    There is a possibility of transitioning from the triglyceride reagent probe and direct ldl to lipase to rx equipment, which may cause elevated lipase results. this can occur if lipase is directly positioned before or after triglycerides or direct ldl in the order of assays in these equipment.
  • Action
    Update the reagent installation with the correct settings using the data provided by the manufacturer (Letter to the attached clients). Field action classification: Aldolase specific application protocol for Rola Imola equipment Field action code: 7f06.0001

Device

Trade name: LIPASE RANDOX. Technical Name: LIPASE. ANVISA registration number: 80158990110. Risk ...

Manufacturer

RANDOX BRASIL LTDA; RANDOX LABORATORIES LTD