Events

Safety Alert for CELL DYN 4000 WBC - Reagent - Part A LN 1H77-01. lot: 8928212

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL 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
    706
  • Date
    2003-03-12
  • 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
    Discontinue use of CELL DYN 4000 WBC Reagent - Part A LN 1H77-01, lot: 8928212, expires May 31, 2003, keep the product in its inventory (ideal conditions) and notify the distributor / Abbott Laboratories for be withdrawn for destruction and bonuses. For more information, please contact the CUSTOMER SERVICE CENTER at 0800-119099.
  • Reason
    Random bacterial contamination in cell dyn 4000 wbc reactant - part a, no. 8928212, valid may 31, 2003. the contaminant is pseudomonas species and may sporadically result in an increase in the wbc background count, ? " and increased lymphocyte or false positive nrbc s variants.
  • Action
    Discontinuation of lot 8928212 beginning on 02/28/2003 by means of letters to clients.

Device

CELL DYN 4000 WBC - Reagent - Part A LN 1H77-01. lot: 8928212

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA