Events

Safety Alert for DIAGNOSTIC KITS, DEHYDROGENASE LACTATE LD-P. BATCH NUMBER 030004 EXPIRING 21 / MAY / 2001.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by SISTEMAS DE ANÁLISES MÉDICOS..

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
    8
  • Date
    2001-03-14
  • 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
    Stability tests indicated that useful life is less than expected. control and patient values may be below real.
  • Action
    THE MANUFACTURER STARTED WITHDRAWAL ON DECEMBER 19, 2000. RELEVANT LABORATORIES MUST CHECK THAT THEY RECEIVED THE NOTIFICATION OF THE MEDICAL ANALYSIS SYSTEMS. YOU MUST IDENTIFY AND REMOVE THE AFFECTED PRODUCTS FROM YOUR INVENTORY. THE LABORATORY MANAGER MUST COMPLETE THE FORM AND REQUIRE REPLACEMENT OF THE AFFECTED KITS, AT FAX 00XX1 (805) 987-6498. FOR FURTHER INFORMATION, TELEPHONE TO PHARMACY, 00XX1 (805) 987-7891.

Device

DIAGNOSTIC KITS, DEHYDROGENASE LACTATE LD-P. BATCH NUMBER 030004 EXPIRING 21 / MAY / 2001.

Manufacturer

SISTEMAS DE ANÁLISES MÉDICOS.
  • Source
    ANVSANVISA