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

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    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.
  • Reason
    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.