Events

Alerta De Seguridad para Reagents, immunoassay, control, toxicology ,. Controls Multiconstituent X Systems for Drug Testing Addition of List Number: 09687-12; Number of lots: 72409M100 EXP OCT 31 2001, 74338M300 EXP NOV 30 2001

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

¿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
    340
  • Fecha
    2001-11-16
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The methadone concentrations of the above kits were manufactured at methadone concentrations below the target value. this may result in out-of-range control values ​​inserted into the kit when tested with adx, tdx / tdxflx or axsym methadone reagents. the manufacturer states that no other analyzer in the above kits has been affected.
  • Acción
    Please verify receipt of the product recall letter dated June 14, 2001 from Abbott Laboratories. Identify and isolate all affected products in your inventory. Please retain and attach the product correction letter including Annexes I and II describing the new limits for batches of the above methadone components for your laboratory records. Reestablish the limits of variation of laboratory controls for the above methadone components based on the charts provided in the charts sent by Abbott Laboratories. If you have shipped this product to other laboratories, Abbott requests that you inform the units of this removal. For more information, please contact your local representative. ANVISA is interested in following if there has been good collaboration of the manufacturer | your laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Reagents, immunoassay, control, toxicology ,. Controls Multiconstituent X Systems for Drug Testin...

Manufacturer

Abbott Laboratories
  • Source
    ANVSANVISA