Alerta De Seguridad para m2000sp instrument

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Medical device safety alert: abbott laboratories m2000sp instrument medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning m2000sp instrument, with affected list number 09k14. all assays run on the m2000sp instrument that require manual entry of calibrator and control expiration dates, lot numbers, and calibrator and control concentration values were affected. according to the manufacturer, there was an issue on the m2000sp instrument software when information is entered incorrectly during the creation of a sample extraction test order. an issue may occur only when the correction is made to manually entered calibrator or control information after the operator have progressed beyond the "sample extraction: sample scan" screen and the operator do not re-scan the sample tubes and racks after data correction on the "sample extraction: assay detail" screen. an issue with the m2000sp instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the sample extraction assay details screen, the changes are not saved. this software issue will occur if some specific steps are followed. furthermore, the manufacturer advises users that when entering calibrator or control information on the sample extraction: assay details screen, verify that the information is correct prior to proceeding to tile next screen. if identifying that the entered information is incorrect, users can correct the information by following options or steps suggested by the manufacturer. the manufacturer will deploy a new corrective software upgrade by the end of first quarter 2013. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 17 december 2012.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Laboratories m2000sp instrument
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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