Events

Alerta De Seguridad para ARCHITECT SHBG REAGENT / ARCHITECT SHBG REAGENT Technical Name: GLOBULIN-CONTAINED SEXUAL HORMONE (SHBG) ANVISA Registration Number: 80146501359 Hazard Class: II Affected Model: Not applicable Affected serial numbers: 01916E000, 00316F000, 01816G000, 00916I000 , 07316I000, 00916L000, 01816E000, 00216F000, 01716G000, 00816I000 and 07216I000.

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 GmbH & Co. KG..

¿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
    2297
  • Fecha
    2017-05-22
  • 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
    1) Immediately discontinue the use of potassium EDTA-type tubes with the ARCHITECT SHBG assay according to your laboratory procedures. 2) Review this statement with your Medical Officer to ensure that he or she is aware of the problem and to decide whether a review of previously generated results is required using potassium EDTA-type sample tubes. 3) 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. 4) Please complete and submit the Customer Response Form. 5) Keep a copy of this statement in your lab files. #### Update of the field action: UPDATED ON 09/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    Abbott has identified that the results of the architect shbg assay generated with the potassium edta-type tube may demonstrate a negative change from the results generated with serum samples. disruption of shbg dimer in edta may result in low shbg measurements by immunoassays *. all currently valid batches of reagent stock are impacted. * fillmore cm, fear tr, hoover rn et al. biomarkers: biochemical indicators of exposure, response, and susceptibility to chemicals. biomarkers 2000; 5 (5): 395-398.
  • Acción
    Field Action Code FA18APR2017 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

ARCHITECT SHBG REAGENT / ARCHITECT SHBG REAGENT Technical Name: GLOBULIN-CONTAINED SEXUAL HORMONE...

Manufacturer

Abbott Laboratórios do Brasil; Abbott GmbH & Co. KG.
  • 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