Events

Alerte De Sécurité sur ARCHITECT TOXO IgG REAGENT KIT - Registration 80146501513 - Lots Affected: 15070LI00 and 15070LI01.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ABBOTT LABORATÓRIOS DO BRASIL LTDA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1160
  • Date
    2012-08-10
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    A false reactive result for the Toxo IgG test would lead to a misdiagnosis that the patient would be immune to Toxoplasmosis. In the case of a pregnant patient, this type of diagnosis could avoid monitoring during pregnancy, which would lead to loss of early detection of infection and subsequent therapeutic intervention. There is potential for occurrence of results from falsely reactive patients at an estimated incidence of 2.65%. According to the Company's Action Plan, the term for this Field Action is OUT / 2012. Anvisa accompanies this Action.
  • Cause
    Abbott laboratories has identified that affected batches of this reagent are exhibiting reduced specificity, which may yield higher iu / ml values, leading to a greater number of gray zone or reactive results.
  • Action
    Verify that you are using or have the affected batches of the ARCHITECT Toxo IgG test stocked, discontinue use immediately, segregate the kits as they will be collected and replaced by Abbott Laboratories.

Device

ARCHITECT TOXO IgG REAGENT KIT - Registration 80146501513 - Lots Affected: 15070LI00 and 15070LI01.

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA