Events

Alerta De Seguridad para HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Abbott Molecular Inc..

¿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
  • Fecha
    2012-03-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120316.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: abbott molecular hcv genotype ii m2000 system row combined application cd-rom version 3.0 medical device manufacturer, abbott molecular inc., has issued a field safety notice concerning hcv genotype ii m2000 system row combined application cd-rom version 3.0 (list no: 8l36-03). according to the manufacturer, internal software development testing identified that when running the hcv-gt ii assay, if four or more genotype calls are present for a sample, the software does not generate a result (printed or displayed). instead a blank field is reported. this observation will only occur when running: m2000rt instrument system software v4.0 and v5.0 and hcv genotype ii m2000 system row combined application cd-rom version 3.0. there have been no reports from customers in regards to this observation. if you are in possession of the products, please contact your supplier for necessary action.

Device

HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Molecular HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0
  • Manufacturer
    Abbott Molecular Inc.

Manufacturer

Abbott Molecular Inc.
  • 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
    DH