Alerta De Seguridad para VITROS IMMUNODIAGNOSIS CALIBRATOR * ECi FOR T4TOTA L, Registration nº 10132590390 and VITROS IMUNODIAGNOSTIC REAGENT KIT * ECi FOR TOTAL T4, Registration nº 10132590400 - lot 1590 - See Annex 1 - Distribution List

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1366
  • Fecha
    2014-02-25
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    The company informs that if the service identifies this problem, the VITROS ® System may have had a calibration failure or have presented lower than expected quality control results after the successful calibration of Lot 1590. If the control results are negatively biased, suspect that patient outcomes have been affected, consult your medical director in your laboratory to address any concerns you may have regarding the results of previously reported patients. The company informs that this is a situation in which the use or exposure to the affected product may cause temporary or clinically reversible adverse health consequences, or where the likelihood of a serious adverse health consequence is remote
  • Causa
    The registrant reports that lower than expected quality control results have been observed using vitros ® total t4 reagent packs, lot 1590. results from the patient sample may also have been affected as the quality control results. there were reports of inability to calibrate by using vitros ® total t4 calibrators, lot 1590.
  • Acción
    The company directs customers to immediately discontinue the use of all units in inventory of VITROS® Total T4 1590 batch and reagent pack. Lot 1590 should be discarded from inventory. The quality control results generated from Lot 1590 should be analyzed. If quality control results are negatively biased and patient results are suspected, the service should consult with your Medical Director in your laboratory to resolve any concerns you may have regarding the results of previously reported patients. Further information in a letter to the Client (Annex 2)

Manufacturer