Events

Safety Alert for AEROSET DIRECT HDL - Reg. ANVISA Nº 10055310818, Nº LIST 7D67-01, LOTES 86027HW00

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 - DIVISÃO DIAGNÓSTICOS.

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
    743
  • Date
    2003-07-03
  • 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
    Check if there are any batches in your stock. If you do, please contact ABBOTT LABORATORIOS DO BRASIL LTDA, by calling 0800-119099 or your local representative, in order to make the return and consequently the replacement of the same. The UTVIG - Technovigilance Unit is monitoring the entire collection, return and replacement process until it closes.
  • Reason
    Calibration errors, calibration failures, and low control results out of range before expiration date of reagents. the investigation with the raw material manufacturer indicated that the reduction in the enzymatic potency of the reagent, leading to loss of stability, can be caused by the interaction of two materials. aeroset hdl direct reagent, batch no. 86027hw00 and 89150hw00, may show loss of product stability before expiration date.
  • Action
    Identify whether you are currently using or have lots # 86027HW00 and 89150HW00 in stock, discontinue use and store for later return.

Device

AEROSET DIRECT HDL - Reg. ANVISA Nº 10055310818, Nº LIST 7D67-01, LOTES 86027HW00

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA - DIVISÃO DIAGNÓSTICOS
  • Source
    ANVSANVISA