Events

Alerte De Sécurité sur Access BR Monitor

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

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
    2017-04-18
  • Date de publication de l'événement
    2017-04-18
  • 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_20170418a.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: beckman coulter access br monitor medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its access br monitor for use with the access family of immunoassay systems [reference 387620; all non-expired lots and future lots]. following biases observed in the results of the french national quality controls, the manufacturer has been informed that a study completed by the french competent authority agence nationale de sécurité du medicament et des produits de santé (ansm) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu). according to the manufacturer, the ansm’s preliminary study demonstrated that 10 out of 27 patients diagnosed with cancer in non-remission had a result below the access br monitor url. the manufacturer is evaluating the access br monitor cutoff. the conclusions of this evaluation are planned by the third quarter of 2017. affected users are advised to ensure their laboratory staff and clinicians are aware of the limitations of the access br monitor assay found in the ifu. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2017.

Device

Access BR Monitor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter Access BR Monitor
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter