Events

Alerta De Seguridad para vitros chemistry products specialty diluent and vitros chemistry products fs diluent pack 3

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Ortho Clinical 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
    2014-03-28
  • Fecha de publicación del evento
    2014-03-28
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140328a.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: ortho clinical diagnostics vitros chemistry products specialty diluent and vitros chemistry products fs diluent pack 3 medical device manufacturer, ortho clinical diagnostics, has issued a medical device safety alert concerning its vitros chemistry products specialty diluent lot f3168 (product code 8559825) & vitros chemistry products fs diluent pack 3 lot 01-3266 (product code 6801754). the manufacturer confirmed reports of lower than expected c-reactive protein (crp) results when using the affected lots of vitros specialty diluent and vitros fs diluent pack 3 to dilute samples tested on vitros crp slides. when using the affected lots of diluent, results using vitros crp slides may be negatively biased by approximately 51% using a 3x dilution factor. the manufacturer advises affected users to take the following actions:- immediately discontinue using and discard all remaining inventory of vitros specialty diluent, lot f3168 and/or vitros fs diluent pack 3, lot 01-3266. review previously reported results using the affected lots. discuss any concerns regarding previously reported results with their laboratory medical director or with the requesting physician. according to the manufacturer, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 mar 2014.

Device

vitros chemistry products specialty diluent and vitros chemistry products fs diluent pack 3
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3
  • Manufacturer
    Ortho Clinical Diagnostics

Manufacturer

Ortho Clinical Diagnostics