Events

Alerta De Seguridad para Sure-Guard Pregnancy Test Kit

Según Food and Drug Administration Philippines, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Philippines que fue producido por N/A.

¿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
  • Número del evento
    2018-157
  • País del evento
    Philippines
  • Fuente del evento
    FDAP
  • URL de la fuente del evento
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/505153-fda-advisory-no-2018-157
  • Notas / Alertas
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • Notas adicionales en la data
  • Causa
    Fda advisory no. 2018-157 lifting the advisory of sure-guard pregnancy test kit under fda advisory no. 2018-130, subject “public health warning against the purchase and use of the unregistered medical device product sure-guard pregnancy test kit” the food and drug administration (fda) informs the public that the advisory on the medical device product “sure-guard pregnancy test kit” under fda advisory no. 2018-130 dated 06 april 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations. the medical device product is registered with certificate of product registration no. ivdr-00229 under company amb hk enterprises, inc. the issuance of this advisory shall not in any manner preclude this office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.  for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it. .   attachments: fda advisory no. 2018-157.Pdf.

Device

Sure-Guard Pregnancy Test Kit
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP