Events

Alerte De Sécurité sur Commercial Name: Reactive Dry Vitros for ProteinC Reactive CRP / Dry Reactive Vitros for ProteinC Reactive CRP Technical Name: C Reactive Protein / Protein C Reagent ANVISA Registration Number: 10132590348 Hazard Class: II Affected Model: Box with 5 cartridges x 50 slides / Box with 5 cartridges x 18 slides Serial Numbers Affected: VITROS Chemistry Products PCR Slides; Product Codes: 1926740 and 8097990. Considering the scope of the affected lots (already distributed and possible commercialization), the list of customers using the inputs affected by this field action was considered based on the equipment purchased.

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
    2112
  • Date
    2016-11-28
  • 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
    Follow the instructions in the alert letter to perform dilutions when processing samples above the PCR measurement range. VITROS PCR Slides Instructions for Use (IFUs) will be revised to include additional instructions to follow when diluting samples with results above the measurement range. Meanwhile, keep the notification as verification of the reviewed process for processing samples above the measurement range.
  • Cause
    Ortho clinical diagnostics (ortho) received pcr reports with positive deviation when using vitros pcr slides for sample dilution. vitros chemistry products pcr slides products quantitatively measure c-reactive protein (crp) concentration in serum and plasma using the vitros 250/350 / 5.1 fs and 4600 systems and the vitros 5600 integrated system.
  • Action
    Field Action Code 16000165 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

Commercial Name: Reactive Dry Vitros for ProteinC Reactive CRP / Dry Reactive Vitros for ProteinC...

Manufacturer

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