Events

Alerte De Sécurité sur 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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1366
  • Date
    2014-02-25
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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
  • Cause
    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.
  • Action
    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)

Device

VITROS IMMUNODIAGNOSIS CALIBRATOR * ECi FOR T4TOTA L, Registration nº 10132590390 and VITROS IMUN...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda