Events

Alerte De Sécurité sur COMMERCIAL NAME: IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR TROPONIN I - REGISTRATION NUMBER: 10132590479 / LOTS: 3151 E 3170

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 Ortho Clinical Diagnostics.

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
    869
  • Date
    2007-05-11
  • 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
    According to the company there is record of import and distribution of affected lots, and that the company has already started the collection process with its customers and that all affected products found in stock were blocked for sale and transferred to the quarantine site. which has already identified all the products located in stock and customers, for which the products in were sent, already having been sent the notice of collection. The UTVIG - Technovigilance Unit will be monitoring the entire collection process.
  • Cause
    The ability of certain product units to provide negatively tendentious results at concentrations below 0.20ng / ml (μg / l), this failure may be reflected in negatively tending results that affect both patient samples and positive control fluid from low level. patients with very low concentrations of troponin i may be negatively tendentious and reported incorrectly as lower than the upper reference limit (url) of 0.08ng / ml (μg / l). results greater than 0.2 ng / ml (μg / l) are not affected by this failure.
  • Action
    Statement of recollection; Request to customers to discard the remaining inventory of the lots in question.

Device

COMMERCIAL NAME: IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR TROPONIN I - REGISTRATION NUMBER: 1013...

Manufacturer

Ortho Clinical Diagnostics