Events

Alerta De Seguridad para IMMAGE Immunochemistry Systems Cuvette Sectors

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

¿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
    2017-03-01
  • Fecha de publicación del evento
    2017-03-01
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170301.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: beckman coulter immage immunochemistry systems cuvette sectors medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its immage immunochemistry systems cuvette sectors [part number (p/n): 470706; all lot]. the manufacturer has determined that immage cuvette sectors (p/n 470706) may be missing one of two positioning pins. cuvette sectors missing a positioning pin can become misaligned. if a cuvette sector becomes misaligned, under rare circumstances, the instrument mixer paddle may rub against the inside wall of the cuvette and create a noise. the manufacturer has no evidence of erroneous results being generated due to this issue to date. the manufacturer is instructing affected users to take the following actions:- inspect the cuvette sectors on the instrument reaction wheel to determine if any are missing positioning pins. replace any cuvette sectors with missing pins. upon completion of inspection, confirm that all cuvette sectors are seated in the reaction carousel. inspect the spare parts inventory of cuvette sectors to determine if any are missing positioning pins. discard any cuvette sector with missing positioning pin. a retrospective review of results is not necessary. 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 01 march 2017.

Device

IMMAGE Immunochemistry Systems Cuvette Sectors
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter IMMAGE Immunochemistry Systems Cuvette Sectors
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter