Events

Alerta De Seguridad para Trade name: CELL-DYN RUBY Technical name: HEMATOLOGICAL ANALYZER ANVISA registration number: 80146501507 Hazard class: II Affected model: Not applicable

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.

¿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
    2229
  • Fecha
    2017-03-17
  • 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. Your Abbott service team will contact you to replace the PCBA Pump Relay Plate on the impacted equipment (s) at no cost. 2. Make sure you have a back-up device or alternate method to generate hematology results if the equipment becomes inoperative. 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. Keep this statement in your lab files.
  • Causa
    Abbott hematology has learned that the cell-dyn ruby equipment in its laboratory has a printed circuit board (pcba) assembly that may fail prematurely and result in loss of vacuum / pressure. the pcba pump relay board failure will result in system started messages (sims), including but not limited to the following, and will no longer function: 0840 vacuum accumulator # 1 wet, 1093 mix head failed to complete downward rotation, 1095 mix head not top position, 1096 mix head stuck at top position, 0643 wbc lyse empty * [empty wbc lysis reagent *], 0645 dil / sheath empty *. for messages 0643 and 0645, make sure that the reagent is not empty. if the error message is related to this problem, the machine will stop and you will need to replace the pcba to continue.
  • Acción
    Field Action Code FA13FEB2017 Revision 01 released under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will make correction in the field.

Device

Trade name: CELL-DYN RUBY Technical name: HEMATOLOGICAL ANALYZER ANVISA registration number: 8014...

Manufacturer

Abbott Laboratórios do Brasil; ABBOTT LABORATORIES
  • 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