Events

Alerta De Seguridad para ARCHITECT TESTOSTERONE - Records 80146501466, 80146501467, 80146501468. Affected Lots - 11907JN01, 13909JN01, 15909JN01, 15916JN00, 1897JN01, 18907JN02, 201901JN01, 11907JN00, 13909JN00, 15909JN00, 15916JN01, 18907JN00, 21901JN03, 21901JN04, 17342JN00, 19142JN00, 19142JN01, 19142JN02, 22270JN00 , 23277JN00, 23277JN01, 17203JN00, 19075JN00, 22121JN00 and 23199JN00.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL LTDA.

¿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
    1222
  • Fecha
    2013-01-15
  • 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
    Exposure to materials containing Methylisothiazolones may cause an allergic skin reaction. Personal protective equipment should be used in accordance with your laboratory practice to ensure adequate protection against such an event. This warning is not a result of any adverse events reported in relation to the product marketed. Anvisa follows this Field Action. #### UPDATE - 04/29/2013 - CLOSURE of the action communicated by the company.
  • Causa
    The current architect testosterone reagents, calibrators and controls labels do not contain warnings and precautions applicable to materials containing methyl-isotiazolones, classified as skin sensitizers.
  • Acción
    The company recommends to professionals users: 1) Treat this product as skin sensitizer. 2) If you have forwarded the products listed in the List of Affected Lots list distributed in Brazil to other laboratories, please provide a copy of this notice to the laboratory in question. 3) Keep a copy of this notice for future reference. 4) The instructions for use shall be corrected from the following lots: ARCHITECT Reagents Testosterone, from lot 24900UI01 - Reagents ARCHITECT Testosterone, from lot 24900UI00 - ARCHITECT Testosterone Calibrators, from lot 24912UI00 - Controls ARCHITECT Testosterone, from from lot 24911UI00

Device

ARCHITECT TESTOSTERONE - Records 80146501466, 80146501467, 80146501468. Affected Lots - 11907JN01...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA