Alerta De Seguridad para IRISpec CA/CB/CC control

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

¿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
    2017-08-30
  • Fecha de publicación del evento
    2017-08-30
  • País del evento
  • Fuente del evento
    DH
  • 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: beckman coulter irispec ca/cb/cc control beckman coulter has issued a medical device safety alert concerning the irispec ca/cb/cc control, manufactured by iris diagnostics. [reference numbers: 800-7702 and 800-7702-fjr]. the manufacturer has become aware of an issue in which results for the irispec cb control for urobilinogen may fall below the lower limit of the stated quality control range. the irispec cb control may intermittently fail for the urobilinogen analyte when run on the ichemvelocity. the customer’s laboratory will be unable to process patient samples until quality control passes. this will not affect patient sample results. a new lower limit on the urobilinogen control range is being implemented to align the published ifu range with that of the allowable product claims per beckman coulter’s design requirements. the irispec ca/cb/cc package insert (and strip package insert information related to controls) will be updated to reflect changes to the lower limit of the qc range. customers are recommended to take the following actions: implement the use of the following revised quality control ranges for irispec cb urobilinogen for the ichemvelocity refer to the ichemvelocity operato’s manual (p/n 300-4449fe, appendix a; entering consumables data) to change the qc range or contact the manufacturer for assistance. disregard any information related to control specifications that are outlined in strip package insert. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 august 2017.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter IRISpec CA/CB/CC control
  • Manufacturer

Manufacturer