Events

Safety Alert for CREATININE REAGENTS COBAS MIRA, ALL LOTS

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; RAICHEM DIV HEMAGEN DIAGNÓSTICOS INC..

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
    4
  • 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
    These reagents may produce false, high creatinine results due, but not limited to, high serum levels of triglycerides. roche started the urgent removal day december 20, 2000.
  • Action
    PLEASE CHECK THAT YOU HAVE RECEIVED THE ROCHE DIAGNOSTIC CORRECTIVE LETTER OF DECEMBER 20, 2001. IDENTIFY AND DISCONTINUE THE USE OF ALL PRODUCTS THAT MAY BE AFFECTED AND ARE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT DAGNOSTIC ROCHE ON THE PHONE.

Device

CREATININE REAGENTS COBAS MIRA, ALL LOTS

Manufacturer

ROCHE DIAGNÓSTICOS CORP. SUB F HOFFMANN-LA ROCHE LTDA; RAICHEM DIV HEMAGEN DIAGNÓSTICOS INC.
  • Source
    ANVSANVISA