Events

Alerta De Seguridad para FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH

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

¿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
    2014-03-11
  • Fecha de publicación del evento
    2014-03-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140311.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 fb (fast blue bb), zym b reagent, api listeria, and api nh medical device manufacturer, biomerieux, has issued a field safety notice (fsn) concerning certain lots of biomerieux fb (fast blue bb) with reference number 70562, zym b reagent with reference number 70493, api listeria with reference number 10300, and api nh with reference number 10400. identification strips using the fb reagent: api campy (20800), id 32 staph (32500), rapid id 32a (32300), rapid id 32 strep (32600) identification strips using the zym b reagent: api 20 strep (20600), api coryne (20900), api staph (20500), api zym (25200), api nh (10400), api listeria (10300) the issue may result in misidentification of microorganisms. the manufacturer advises users of the followings: if users are in possession of some kits of fb reagent (70562), they should implement the mandatory requirements as mentioned in the fsn. if users are in possession of some kits of zym b (70493), api nh (10400) and api listeria (10300), they should check the aspect of zym b (70493) before each use and follow the recommendations mentioned in the fsn. users should discuss with the laboratory director to evaluate the impact and determine if any retrospective analysis of results is required. for the next batches, an insert will be added in fb reagent (70562), zym b (70493), api nh (10400) and api listeria (10300) to explain the mandatory actions required in this fsn. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 march 2014.

Device

FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Biomerieux FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux