Events

Alerta De Seguridad para chromID Strepto B Agar

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

¿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
    2012-10-31
  • Fecha de publicación del evento
    2012-10-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121031b.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
    Medical device safety alert: biomerieux chromid strepto b agar the health canada posted a medical device safety alert concerning chromid strepto b agar [ref. no.: 43461; lot 1001508710; expiry date: 30 october 2012] manufactured by biomerieux sa. biomerieux could not guarantee the characteristic coloration of the streptococcus b colonies at 24 hours and 48 hours of incubation. false negative results could lead to incorrect diagnostic resulting to a serious deterioration in state of health of patients. according to the local supplier, the affected products were distributed in hong kong. for details, please visit the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_oct-dec_2012-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 october 2012.

Device

chromID Strepto B Agar
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Biomerieux chromID Strepto B Agar
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA