Events

Alerta De Seguridad para PATHFAST CK-MB AND PATHFAST NTproBNP REAGENTS

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
    2018-206
  • 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/514569-fda-advisory-no-2018-206
  • 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. 2018-206 voluntary recall of the pathfast ck-mb and pathfast ntprobnp reagents  all are hereby advised by the food and drug administration (fda) on the voluntary recall of pathfast ck-mb with lrd/cdrrhr_exemp-2015-6374 and pathfast ntprobnp with lrd/cdrrhr_exemp-2015-6372 distributed by global medical solutions, inc., with business address at 3/f 14 economia st., bagumbayan, quezon city with the following information: product name catalogue no. lot no. pathfast ck-mb pf1031-k 0769 pathfast ntprobnp                pf1061-k 0768 pathfast ntprobnp                pf1061-k 0769 the cited medical device was voluntarily recalled by global medical solutions, inc. due to the several reagent cartridges had tiny pinhole on the aluminum seal at the well position of alkaline phosphatase labelled antibody reagent which was generated during the filling process. in case the reagent leaked through the pinhole, the appropriate result may not be obtained. the above recalled medical device products might results in deviation of accuracy of the data if reagent leakage occurs through the pinhole.    distributors, retailers, hospitals that have any lot of the stated medical device product are instructed to discontinue further distribution, sale and use. all consumers are likewise advised not to purchase or use the affected product lots.  any suspected adverse reaction experienced or any incident of the same cases from the use of the device but not limited to the lots stated above, should be reported immediately to fda at telephone no. (02) 857-1900 loc. 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested.      attachments: fda advisory no. 2018-206.Pdf.

Device

PATHFAST CK-MB AND PATHFAST NTproBNP REAGENTS
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP