Events

Safety Alert for SAMPLE CONTAINERS USED WITH ROCHE / HITACHI AND ELECSYS ANALYSIS

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
    1
  • 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
    The space of the liquid reservoir in the sampling containers is defective and can break, commit the volume and possibly give incorrect reading. roche started the urgent removal day 1o. of february 2001.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE ROCHE URGENT CORRECTIVE LETTER DIAGNOSTICS OF THE DAY 1O. OF FEBRUARY 2001. IDENTIFY AND DISCONTINUE THE USE OF ALL THOSE AFFECTED PRODUCTS THAT ARE IN YOUR INVENTORY. DO NOT USE THEM IN YOUR ANALYZER. FOR FURTHER INFORMATION CONTACT DAGNOSTIC ROCHE ON THE PHONE.

Device

SAMPLE CONTAINERS USED WITH ROCHE / HITACHI AND ELECSYS ANALYSIS

Manufacturer

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