Events

Alerte De Sécurité sur VIDAS 3 system

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par BioMérieux.

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
  • Date
    2013-12-23
  • Date de publication de l'événement
    2013-12-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131223.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: biomérieux vidas 3 system medical device manufacturer, biomérieux, has issued a medical device safety alert concerning its vidas 3 system [catalogue number: 412590]. the manufacturer was informed that some customers experienced pipetting issue on the instrument vidas 3 ref. 412590 when they use tubes with an external diameter of around 12 mm. the issue is due to a collision between a small flat step at the top of the tip and the tube edges when the pipettor is going down to aspirate in the tube. the instrument identifies the problem and errors 0956 xapu and/or 0502 (loading bay errors) happen. there is no risk to have an incorrect diagnostic because the error message will occur before having a diagnostic result. the manufacturer advises users to stop using the tubes size of 12 mm and to use tubes with a larger diameter (13 and/or 16 mm as per user manual) until corrective actions are implemented. the user manual will be updated based on the investigation results. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 december 2013.

Device

VIDAS 3 system
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BioMérieux VIDAS 3 system
  • Manufacturer
    BioMérieux

Manufacturer

BioMérieux