Events

Alerta De Seguridad para Clongene Biotech CLUNGENE hCG Pregnancy Test

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

¿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
    2014-09-30
  • Fecha de publicación del evento
    2014-09-30
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140930b.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: hangzhou clongene biotech clungene hcg pregnancy test the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning clungene hcg pregnancy test, manufactured by hangzhou clongene biotech co., ltd. with the following details: lot no.: 13122001 and 14060301 types: strip, cassette and midstream the clungene hcg pregnancy test midstream (lot 13122001 and 14060301) gave 17 false positive results at 5 ireland healthcare facilities from 12th june 2014 to 7th august 2014. the manufacturer tested the reserved samples of lot13122001, lot14060301 in the factory and returned 20pcs sticks from distributor, and all test results are passed. the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well. the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 30 sep 2014.

Device

Clongene Biotech CLUNGENE hCG Pregnancy Test
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hangzhou Clongene Biotech CLUNGENE hCG Pregnancy Test
  • Manufacturer
    Hangzhou Clongene Biotech Co.

Manufacturer

Hangzhou Clongene Biotech Co.