Events

Recall Or Safety Alert for ADVIA Centaur® BNP kit, reference numbers 02816634 and 02816138, ADVIA Centaur TSH3 Ultra kit, reference numbers 06491080 and 06491072 together with the ADVIA Centaur Multidiluent 1, reference numbers 07907174 (110313) and 07293184 (110312)

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by N/A.

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
    Recall / Safety Alert
  • Date
    2012-08-13
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Event Source URL
    N/A
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 recall data from the U.S. and Spain.
  • Extra notes in the data
  • Action
    Decrease in the stability of the Multidiluent 1 stored on board the ADVIA Centaur and ADVIA Centaur XP systems, which may cause a decrease in the recovery in samples with high values ​​of BNP and TSH-3 that have required dilution.

Device

ADVIA Centaur® BNP kit, reference numbers 02816634 and 02816138, ADVIA Centaur TSH3 Ultra kit, re...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    AEMPSVFOI