Events

Alerte De Sécurité sur BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit

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

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
    2017-07-31
  • Date de publication de l'événement
    2017-07-31
  • 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_20170731.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: bd max vaginal panel and bd max uve specimen collection kit medical device manufacturer, bd, has issued a medical device safety alert concerning its bd max vaginal panel [catalogue number: 443712, 443710] and bd max uve specimen collection kit [catalogue number: 443376]. the manufacturer is currently conducting an investigation into customer complaints regarding an increased rate of unresolved (unr) and indeterminate (ind) results for the bd maxtm vaginal panel. a non-reportable result may lead to repeat of the test and/or re-collection of a specimen. data from the investigation suggest that this issue is related to certain specimen collection practices, including the use of lubricants. information is intended to provide clinicians and patients with precautions in relation to current package insert instructions included with bd max uve specimen collection kits. product returns or discards are not required. clinicians and patients are advised to follow the precautions provided by the manufacturer. 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 31 july 2017.

Device

BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit
  • Manufacturer
    BD

Manufacturer

BD