Events

Alerte De Sécurité sur VIDAS D-Dimer Exclusion II

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
    2013-01-23
  • Date de publication de l'événement
    2013-01-23
  • 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_20130123a.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 d-dimer exclusion ii health canada has posted a medical device safety alert concerning vidas d-dimer exclusion ii manufactured by biomérieux. the affected model/catalogue and lot/serial numbers are 30455 and 1001399220 respectively. the manufacturer has registered two complaints on false negative results under the detection limit (<45 ng/ml) using the batch 1001399220. the investigation indicates that there is the potential for a manufacturing issue to be the cause of the problem and root cause investigations are in-process. the impact of a false negative d-dimer test result could be critical for the patient because it could prevent further diagnostic workup for venous thromboembolism and withhold anticoagulant treatment when it is actually needed, resulting in a negative impact to patient care. as a preventive measure, biomérieux has decided to remove the suspect product from the field. furthermore, all affected users are advised to take the following necessary actions: stop using and destroy the affected products. perform a retrospective analysis of the patients tested on this batch and investigate further (e.G. final diagnosis and clinical status of the patient) if the result is < 45 ng/ml. according to the local supplier, the affected products are distributed in hong kong. for details, please visit the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/ rec-ret_md-im_date_jan-mar_2013-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 23 january 2013.

Device

VIDAS D-Dimer Exclusion II
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biomerieux VIDAS D-Dimer Exclusion II
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux