Events

Alerta De Seguridad para SEROLATEX PRODUCTS - CAT. 56 E 56K - LOTS 0018, 0019 AND 0020. PRODUCTS REUMALATEX PCR - CAT 54 AND 54K

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LABTEST DIAGNOSTICA.

¿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
  • ID del evento
    38
  • Fecha
    2001-07-24
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    PROVIDES THAT THE PRODUCT HAS BEEN COLLECTED FROM THE MARKET SEROLATEX CATALOGOS 56 AND 56K, LOTS 0018, 0019 AND 0020, FOR THE PRESENTATION OF TECHNICAL PROBLEMS, EVEN IF THE PRODUCT WILL HAVE ITS MARKETING AND PRODUCTION DISCONTINUED UNTIL THE END OF DECEMBER 2001, THIS TIME TO TRY SOLVING THE PROBLEM. AND AS A PREVENTIVE MEASURE OPTION TO DISCONTINUE FOR THE SAME PERIOD, THE PRODUCTION AND MARKETING OF THE REUMALATEX PRODUCT CATÁLOGOS 54 AND 54K FOR USING A TECHNOLOGY SIMILAR TO SEROLATEX PCR.
  • Causa
    Technical problems occurring with the supplier's raw material.
  • Acción
    LABTEST DIAGNOSTIC REPORTS THAT THE PRODUCT SEROLATEX CATALOGS 56 AND 56K, LOTS 0018, 0019 AND 0020, FOR THE PRESENTATION OF TECHNICAL PROBLEMS, HAS BEEN OBTAINED FROM THE MARKET, IT FURTHER INFORMES THAT THE PRODUCT WILL HAVE THE MARKETING AND PRODUCTION DISCONTINUED UNTIL THE END OF DECEMBER 2001, PERIOD THIS TO TRY TO SOLVE THE PROBLEM. AND AS A PREVENTIVE MEASURE OPTION TO DISCONTINUE FOR THE SAME PERIOD, THE PRODUCTION AND MARKETING OF THE REUMALATEX PRODUCT CATÁLOGOS 54 AND 54K FOR USING A TECHNOLOGY SIMILAR TO SEROLATEX PCR.

Device

SEROLATEX PRODUCTS - CAT. 56 E 56K - LOTS 0018, 0019 AND 0020. PRODUCTS REUMALATEX PCR - CAT 54 A...

Manufacturer

LABTEST DIAGNOSTICA
  • Source
    ANVSANVISA