Events

Alerte De Sécurité sur VITROS® Chemistry Products Calibrator Kit 9, Lot SKU 8568040 - 0954

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; Ortho-Clinical Diagnostics, Inc..

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
    1721
  • Date
    2015-10-27
  • 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 when condition code U90-382 or 6LU occurs, the VITROS® System hides the result and it is not reported. The increase in condition codes occurs mainly when using the VITROS® DGXN and PHYT Slides. All numerical results obtained are valid provided that no wash error has occurred and the quality control results are within acceptable limits.
  • Cause
    The manufacturer has identified a potential increase in condition codes u90-382 or 6lu (washing errors) when using the product vitros® calibrator kit 9, lot 0954.
  • Action
    The company is instructed to discontinue use of the product and discard all remaining inventory of VITROS® Calibrator Kit 9, Lot 0954 after receiving your replacement request. NOTE: It is acceptable to use Lot 0954 until your replacement request arrives. Recalibrate the VITROS® DGXN and PHYT Slides using the Cal Kit 9 in your installation, with an alternative batch of the calibrator, if available. Place this notification on each VITROS® System or along with the user documentation. Fill out and return the Receipt Confirmation Form. Further information: Annex I

Device

VITROS® Chemistry Products Calibrator Kit 9, Lot SKU 8568040 - 0954

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics, Inc.