Events

Alerta De Seguridad para Monoclonal Mouse, Anti-Pneumocystis Jiroveci, Clone 3F6

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

¿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
    2018-307
  • 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/526276-voluntary-recall-of-monoclonal-mouse-anti-pneumocystis-jiroveci-clone-3f6-with-product-code-m0778
  • 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
    The food and drug administration (fda) informs the public and all concerned healthcare professionals that mmj biosystem philippines (mmj), inc. has voluntarily recalled the monoclonal mouse, anti-pneumocystis jiroveci, clone 3f6 with product code m0778 with the following lot numbers: 20010445 20030858 20042555 according to mmj, the primary label of the affected vial was mislabeled with an incorrect concentration. for the product code m0778 the concentration was written to be 30 mg/l when the correct concentration is 75 mg/l. mmj further claims that ⁓2.5-fold higher concentration in the vial will have no consequence on the quality of m0778 and the products are expected to perform as usual. lastly mmj claims that if diluted according to the label, the higher concentration will result in stronger signals than expected and may lead to increased background staining and/or false positive staining. positive and negative run controls would detect any problems with staining in this case. in view of the foregoing, distributors, retailers, hospitals and all healthcare professionals / users are advised to discontinue further distribution, sale and use of the said affected medical device product. for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.   attachments: fda advisory no. 2018-307.Pdf.

Device

Monoclonal Mouse, Anti-Pneumocystis Jiroveci, Clone 3F6

Manufacturer

MMJ Biosystem Philippines (MMJ), Inc.
  • Source
    FDAP