Events

Alerte De Sécurité sur VIDAS CA 15-3

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

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
    2018-07-18
  • Date de publication de l'événement
    2018-07-18
  • 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_20180718a.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: biomerieux vidas ca 15-3 medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its vidas ca 15-3 [reference: 30429; lot number: 1006022590 and 1006251930]. following customers’ complaints for calibrations out of range (standard s1 out of range low and/or control c1 out of range high) when using the affected lots, investigators confirmed a defect on the identified products and reproduced the issue reported by the customers. the manufacturer has identified that s1 signal decrease was probably due to a particular lot of raw material (bovine albumin) which is a component of standard s1, which was not performing as expected. the lot of raw material was not used for the manufacturing of any other product. it has been established that standard s1 will continue to decrease over time, what will lead both lots of finished products to be unusable due to invalid calibrations. investigators showed that control c1 is conforming expected specifications. its relative fluorescence value (rfv) does not evolve overtime. the c1 out of range high reported by some customers is not linked to a signal increase but is due to standard s1 decrease. according to the manufacturer, as the vidas systems trigger an alarm in case of invalid calibration, the defect is easily identified. the identified issue can lead to delayed results. there is no risk for false results. the defect (standard s1 signal decrease) can have two impacts on the finished product: standard s1 is obtained out of range low at the opening of the kit: the kit cannot be calibrated and cannot be used, what leads to delayed results. control c1 is obtained out of range high at the time of the recalibration: the kit cannot be calibrated and cannot be used, what leads to delayed results. affected users are instructed to destroy the impacted lots. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 18 july 2018.

Device

VIDAS CA 15-3
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: bioMerieux VIDAS CA 15-3
  • Manufacturer
    bioMerieux

Manufacturer

bioMerieux