Events

Alerta De Seguridad para loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602

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

¿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
    2014-05-26
  • Fecha de publicación del evento
    2014-05-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140526.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: roche loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602 medical device manufacturer, roche, has issued a field safety notice (fsn) concerning roche loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602. based on recently received complaints, the manufacturer has identified that under certain conditions loose procell /cleancell aspiration tube filters might affect results. when the procell / cleancell bottle is almost empty (the liquid level in the procell / cleancell bottle drops below the joint between aspiration tube and the filter), system reagent foam may be created and aspirated into the measuring cell. in case of procell this can cause discrepant results: high for competitive and low for sandwich assays. the magnitude of the discrepancy varies with the amount of air being aspirated. the manufacturer advises users of the followings: special caution should be taken so that the aspiration tube lifter is not dropped after the replacement of the procell / cleancell bottle. users should check that the procell /cleancell aspiration tube filter is properly tightened. if the procell / cleancell aspiration tube filter is blocked and needs to be cleaned, users should ensure that the filter is properly tighten when placing it back after the cleaning process. there will be a change of the “procell / cleancell aspiration tube filter check” from operator’s maintenance to service maintenance. the operator’s manual will be updated accordingly. 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 26 may 2014.

Device

loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Roche Loose ProCell / CleanCell Aspiration Tube Filter on MODULAR ANALYTICS , cobas e601 and cobas e602
  • Manufacturer
    Roche

Manufacturer

Roche