Events

Alerta De Seguridad para Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents

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
    2017-04-24
  • Fecha de publicación del evento
    2017-04-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170424a.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 synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents [reference numbers: 467825 (chol), a60298 (cr-e), a15625 (hdl), a95550 (lact), 445850 (tg and tg-b), 442785 (uric), 378194 (saly); lot numbers: all]. the manufacturer has identified the drugs metamizole (dipyrone), sulfasalazine and sulfapyridine as potential sources of interference when using synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents. with the administration of these drugs, the effects to patient analytes are: metamizole (dipyrone) – may generate false low cholesterol, enzymatic creatinine, hdl cholesterol, lactate, triglycerides and uric acid results. sulfasalazine – may generate false high salicylate results. sulfapyridine – may generate false low salicylate results. information regarding interference with these drugs will be added to the chemistry information sheets (cis) for the respective products. the cis will be updated on the beckman coulter website's technical documents webpage. 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 24 april 2017.

Device

Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and S...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Beckman Coulter Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter