Events

Alerta De Seguridad para IMX T 4 FREE REAGENTS, Reg. No. 10055310036, list no. 2222-20 lot no. 01550Q100 and FREE T4 CONTROLS, Reg. No. 10055311050, list no. 9C03-10, lot no. 95881Q100

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
    738
  • Fecha
    2003-06-25
  • 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
    Check if you received communication from 16.07.2003 of ABBOTT LABORATORIES DO BRASIL LTDA, if you have not received contact ABBOTT LABORATORIES DO BRASIL LTDA by telephone 11 5367000 or your local representative. ----- BRAZIL 10/09/2003 - Date of Beginning of the Collection: 06/16/2003 ---- /////// ---- Completion Date of the Collection 21/08/2003.
  • Causa
    The mid-level control of free t4 controls, lot # 95881q100, showed a high value for the range mentioned in the instructions for use of the product during investigation of an occurrence. the free t4 controls, lot # 95881q101 (lots not received in brazil) is a sublot of 95881q100, from which complaints about the same occurrence of out of range controls were received. the imx mode 1 calibrator, lot # 96726q100 is the batch of calibrator found on the imx t4 free reagents, batches # 01550q100. this batch of mode 1 calibrator was manufactured with the same components as the control batches mentioned. this lot has been shown to produce an underestimation of the free t4 level in patient samples of up to 29%.
  • Acción
    Check if you received communication from 16.07.2003 of ABBOTT LABORATORIES DO BRASIL LTDA, if you have not received contact ABBOTT LABORATORIES DO BRASIL LTDA, by telephone 11 5367000 or your local representative.

Device

IMX T 4 FREE REAGENTS, Reg. No. 10055310036, list no. 2222-20 lot no. 01550Q100 and FREE T4 CONTR...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA