Events

Alerte De Sécurité sur VerifyNow IIb/IIIa 25-Test and 10-Test Kits

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

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
    2014-03-04
  • Date de publication de l'événement
    2014-03-04
  • 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_20140304.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: accumetrics verifynow iib/iiia 25-test and 10-test kits the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning verifynow iib/iiia 25-test and 10-test kits [product codes: 85011 and 85310; reference number: ivd14.014; capa 13-014] manufactured by accumetrics. during its surveillance, the manufacturer has determined that the affected verifynow iib/iiia test kit lots may result in the reporting of an erroneous low platelet aggregation unit (pau) result. corrective actions are being implemented to prevent these issues from affecting future lots of verifynow iib/iiia test kits. the manufacturer has not received any reports of adverse events for these issues. according to the manufacturer, a lower than actual or expected pau values may contribute to excess administration of iib/iiia anti-platelet agents, which has the potential to lead to an adverse event. typically, higher doses of anti-platelet agents are associated with higher risk of bleeding. the manufacturer advises all affected users to check their inventory to determine if they have any affected verifynow iib/iiia test kits. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con382708 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 march 2014.

Device

VerifyNow IIb/IIIa 25-Test and 10-Test Kits
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Accumetrics VerifyNow IIb/IIIa 25-Test and 10-Test Kits
  • Manufacturer
    Accumetrics

Manufacturer

Accumetrics