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
    2014-10-24
  • Date de publication de l'événement
    2014-10-24
  • 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_20141024a.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 [software version: 1.1.0, 1.1.1, 1.1.2; part number.: 412590; serial number.: all]. the manufacturer has identified three (3) anomalies with the vidas 3 system software version 1.1.0, 1.1.1 and 1.1.2. the first anomaly occurs if the user launches a new calibration for a lot of a vidas test, for which an expired calibration already exists, and an instrument error happens during analytical phase (protocol) of the control. under these specific conditions, the software calculates the sample results without flagging them with the message “incomplete calibration”. however, the overall calibration status is flagged as “incomplete” in the calibration screen. the second anomaly concerns the management of the analysis request of the test vidas cmv avidity (cmvu) ref. 30203 and vidas cmv avidity ii (cmva) ref. 413557. the third anomaly concerns the stability of urea buffer used for the test vidas cmvu ref. 30203and vidas cmva ref. 413557 when it is dispensed in the strip. the potential risk associated with the first anomaly is to have a false result. it could concern all vidas 3 reagent parameters. the potential risk associated with the second and third anomalies is to have a false negative result for the test cmv igg ref. 30204 and a false high result for the tests vidas cmvu ref. 30203 and vidas cmva ref. 413557. 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 24 october 2014.

Device

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

Manufacturer

BioMérieux