Events

Alerte De Sécurité sur cobas taqscreen mpx test, version 2.0

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

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
    2012-10-25
  • Date de publication de l'événement
    2012-10-25
  • 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_20121025.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: roche cobas taqscreen mpx test, version 2.0 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning cobas taqscreen mpx test, version 2.0, manufactured by roche molecular systems, inc. according to the manufacturer, the package insert, part no. 05969492190, v.2.0, used with the cobas taqscreen mpx test, version 2.0 for use on the cobas s 201 system, ce-ivd contains incorrect specimen transport stability parameters. the living donor specimen transport stability claim in the specimen collection, storage and handling section of the cobas taqscreen mpx test, version 2.0 ce package insert currently allows users to store blood collected in edta, cpd, cpda1 or cp2d for up to 72 hours at 2-30 °c. the package insert will be revised to inform users that blood collected in edta, cpd, cpda1 or cp2d can only be stored for up to 48 hours at 2-25 °c. the manufacturer advised users to immediately take the following actions: users should begin using the new specimen transport conditions as below: blood collected in edta may be stored for up to 48 hours at 2 - 25°c. blood collected in cpd, cpda1 or cp2d may be stored for up to 48 hours at 2 - 25°c. whole blood samples with hcv titers near 20.4 iu/ml or lower stored under conditions stated above, should be reviewed, as, although unlikely, they possibly could have been impacted by this issue. furthermore, product labeling will be updated with the next kit build by the manufacturer. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con195873 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 25 october 2012.

Device

cobas taqscreen mpx test, version 2.0
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Cobas TaqScreen MPX Test, version 2.0
  • Manufacturer
    Roche Molecular Systems

Manufacturer

Roche Molecular Systems