Events

Alerta De Seguridad para REAGENT KIT ABBOTT TDx / TDxFLx METOTREXATE II (Anvisa Reg. 10055310273) .. List Number: 07A12-60 .. Lot No .: 45050Q100.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATORIES - USA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    885
  • Fecha
    2007-10-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    The reagent kits described (batch 45050Q10) may be in the wrong bottle configuration: the correct order is WSTP and the affected products are sorted in SWTP form. The Technovigilance Unit is following up on this case.
  • Causa
    Incorrect configuration in the order of the bottles of the kit described (lot 45050q10).
  • Acción
    The distributor of the product in Brazil (Abbott Laboratories of Brazil Ltda.) Has already started a field action, sending a letter to the customers affected by the problem. According to the company, the actions required for those working with this diagnostic kit are as follows: (1) Determine if there is any kit in the affected lot (lot # 45050Q100); (2) Inspect each kit from the affected batch and discard any improperly configured kit (SWTP); (3) If you have sent part of the affected lot to another laboratory, send a copy of the company's communication letter to it; (4) Keep a copy of the communication letter for registration purposes in the laboratory.

Device

REAGENT KIT ABBOTT TDx / TDxFLx METOTREXATE II (Anvisa Reg. 10055310273) .. List Number: 07A12-60...

Manufacturer

ABBOTT LABORATORIES - USA
  • Source
    ANVSANVISA