Events

Alerte De Sécurité sur LifeScan OneTouch Select Control Solution

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

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
    2013-02-28
  • Date de publication de l'événement
    2013-02-28
  • 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_20130228a.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: lifescan onetouch select control solution it has come to our attention that medical device manufacturer, lifescan, has initiated a field safety corrective action concerning onetouch select control solution. the affected lot numbers are 2aa1d01 and 2aa2d02. lifescan is voluntarily removing and replacing two lots of onetouch select control solution distributed in russia, ukraine and republic of moldova. the purpose of control solution testing is to confirm that the meter and test strips are working together correctly as a system. the lots of control solution are being replaced because they may not provide an “in range” control test result when used with onetouch select test strips, even though the system is working correctly. as the meter’s user guide and control solution instructions for use state, an out of range control solution test result may mean the meter system is not working properly. this may lead to a delay further blood sugar testing. this issue applies to control solution test results only. the accuracy of patient blood sugar test results is not affected. the manufacturer advises users to immediately discontinue use of the affected products and contact their supplier for product replacement. it also advises users that if having control solution from the affected lots, they may continue to use the blood glucose system while waiting for replacement. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 28 february 2013.

Device

LifeScan OneTouch Select Control Solution
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: LifeScan OneTouch Select Control Solution
  • Manufacturer
    LifeScan

Manufacturer

LifeScan