Events

Safety Alert for SAMPLE CONTAINERS COBAS INTEGRA, LOT NO.000407

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.

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
    43
  • Date
    2001-05-04
  • 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
    These sample containers were erroneely labeled for use in the cobas integra analyzer, but are drawn to the analyzer sees. roche started the urgent removal day march 5, 2001.
  • Action
    PLEASE CHECK THAT YOU HAVE RECEIVED THE ROCHE DIAGNOSTIC CORRECTIVE LETTER ON MARCH 5, 2001. IDENTIFY AND DISCONTINUE THE USE OF ALL PRODUCTS THAT MAY BE AFFECTED AND ARE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR DAGNOSTIC ROCHE REPRESENTATIVE OR DIRECTLY ON THE PHONE (00XX-1-880-428-5074).

Device

SAMPLE CONTAINERS COBAS INTEGRA, LOT NO.000407

Manufacturer

ROCHE DIAGNÓSTICOS CORP. SUB F HOFFMANN-LA ROCHE LTDA
  • Source
    ANVSANVISA