Events

Alerte De Sécurité sur OneTouch Ultra 1x50 Glucose Test Strips

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

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
    2014-12-17
  • Date de publication de l'événement
    2014-12-17
  • 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_20141217.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: onetouch ultra 1x50 glucose test strips the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning onetouch ultra 1x50 test strips distributed by chemilines limited in the united kingdom. the affected batch number is 3621702/001 and the expiry date is oct 2015. the distributor issued a voluntary recall on one batch of onetouch ultra- 1x50 test strips due to an error in the re-packaging process whereby wrong information input in the code box of the primary pack over-label. the primary pack is covering the code on the original manufacturer’s label related to the reading accuracy of the result. that code should be input by the patient into the meter device for reading confirmation. as a result, the patient may experience difficulties using the product for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con484997 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 december 2014.

Device

OneTouch Ultra 1x50 Glucose Test Strips
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: OneTouch Ultra 1x50 Glucose Test Strips
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    DH