Events

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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL LTDA - DIVISÃO DIAGNÓSTICOS.

¿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
    743
  • Fecha
    2003-07-03
  • 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
    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.
  • Causa
    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.
  • Acción
    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