Events

Safety Alert for ELECSYS TEST PIPETTE TIPS 2010, ALL LOTS BEGINNING BY 051

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ROCHE DIAGNÓSTICOS CORP. SUB F HOFFMANN-LA ROCHE LTDA; TREFF AG DA SUIÇA.

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
    3
  • Date
    2001-05-14
  • 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
    Sampling analysis demonstrated that some of these points of pipeta have partially observed openings that can lead to incorrect results. roche started the urgent removal day january 22, 2001.
  • Action
    PLEASE CHECK THAT YOU HAVE RECEIVED THE DIAGNOSTIC ROCHE DIAGNOSTIC CORRECTION LETTER OF JANUARY 22, 2001. IDENTIFY AND ISOLE ALL PRODUCTS THAT MAY BE AFFECTED AND BE IN YOUR INVENTORY. DO NOT USE THEM IN YOUR ANALYZER. FOR FURTHER INFORMATION CONTACT DAGNOSTIC ROCHE ON THE PHONE.

Device

ELECSYS TEST PIPETTE TIPS 2010, ALL LOTS BEGINNING BY 051

Manufacturer

ROCHE DIAGNÓSTICOS CORP. SUB F HOFFMANN-LA ROCHE LTDA; TREFF AG DA SUIÇA
  • Source
    ANVSANVISA