Events

Alerte De Sécurité sur nt-probnp 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 Radiometer.

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
    2018-05-21
  • Date de publication de l'événement
    2018-05-21
  • 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_20180521a.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: radiometer nt-probnp test kits medical device manufacturer, radiometer, has issued a medical device safety alert concerning its nt-probnp test kits, [942-930 lot 13956] the manufacturer has become aware that the date of manufacturing printed on some of the box labels of the affected products is incorrect. the lot is manufactured in january 2018 and should be labeled “2018-01”. some of the boxes are incorrectly labeled “2018-06”. the nt-probnp test kits includes a second box label including a barcode which when scanned will display the correct date of manufacturing, “2018-01”, on the analyzer. furthermore, this second box label shows the correct expiration date, which is december 2018, “2018-12”. according to the manufacturer, the field action relates to china since the incorrect date of manufacturing is printed on a china specific label. there is no risk for the patient due to the fact that the problem described does not affect the product itself and due to the fact that the expiration date is printed correctly. for this reason the customer may continue to use the product. 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 21 may 2018.

Device

nt-probnp test kits
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Radiometer NT-proBNP Test Kits
  • Manufacturer
    Radiometer

Manufacturer

Radiometer