Events

Alerta De Seguridad para ACID LACTIC Technical Name: Lactic Acid ANVISA Registration Number: 80146501641 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: 31497UN14; 09353UN15; 45216UN15; 14596UN15; 37055UN15 and 14782UN16

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; Abbott Laboratories Diagnostics Division..

¿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
    2161
  • Fecha
    2016-11-11
  • 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
    Please forward this notice to your Medical Director. Taking into account the above information, you may continue to use the ARCHITECT Lactic Acid reagent (LN 9D89-21). Complete and return the attached Customer Response Form. If you have forwarded the product listed above to other laboratories, please inform them of this Product Fix and provide a copy of this notice to the laboratory in question. Keep this statement in your lab files.
  • Causa
    Abbott identified negative interference of n-acetylcysteine ​​(nac) with the architect lactic acid reagent (ln 9d89-21). the table in the customer's release and annex describes the levels of interference observed at nac concentrations of 80 mg / l (0.49 mmol / l) and 800 mg / l (4.9 mmol / l).
  • Acción
    Field Action Code FA10OCT2016 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

ACID LACTIC Technical Name: Lactic Acid ANVISA Registration Number: 80146501641 Hazard Class: II ...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Laboratories Diagnostics Division.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA