Events

Alerte De Sécurité sur Oxoid Antimicrobial Susceptibility Testing Disc CPD10 (Cefpodoxime)

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

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
    2013-02-06
  • Date de publication de l'événement
    2013-02-06
  • 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_20130206a.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: thermo fisher scientific oxoid antimicrobial susceptibility testing disc cpd10 (cefpodoxime) medical device manufacturer, thermo fisher scientific issued a medical device safety alert concerning oxoid antimicrobial susceptibility testing disc cpd10 (cefpodoxime) with model number ct1612b and lot number 1275353. according to the manufacturer, a technical investigation has indicated that the affected lot may contain individual discs that are not impregnated with antibiotic. continued use of this lot could result in false indication of resistance to cefpodoxime. after risk assessment, the manufacturer believes the clinical risk of a blank cefpodoxime disc is low. the manufacturer advised the affected customers to: stop using this lot; destroy any remaining stock; review results reported using this lot; and consider retesting and/or seek appropriate expert advice. the manufacturer confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 february 2013.

Device

Oxoid Antimicrobial Susceptibility Testing Disc CPD10 (Cefpodoxime)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc CPD10 (Cefpodoxime)
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific