Events

Alerte De Sécurité sur Remel Vibrio cholerae Inaba agglutinating serum

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
    2013-06-28
  • Date de publication de l'événement
    2013-06-28
  • 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_20130628.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 remel vibrio cholerae inaba agglutinating serum medical device manufacturer, thermo fisher scientific, has issued a field safety notice concerning remel vibrio cholerae inaba agglutinating serum (model no.: zm06/r30165101 and lot no.: 1155581). according to the manufacturer, an internal technical investigation has confirmed that the performance of vibrio cholerae inaba agglutinating serum lot: 1032772 sold separately as r30165101 lot: 1155581 has deteriorated, and is no longer agglutinating with positive cultures in the slide and tube agglutination test. the manufacturer advises customers who have used the affected lot of vibrio cholerae inaba agglutinating serum to review results reported and consider retesting and/or seek appropriate expert advice as a false negative result may have been obtained. furthermore, the manufacturer requests users to destroy any remaining inventory of the affected vibrio cholerae inaba agglutinating serum and contact customer services or local distributor to request replacement product. according to the manufacturer, the affected products were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 june 2013.

Device

Remel Vibrio cholerae Inaba agglutinating serum
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Thermo Fisher Scientific Remel Vibrio cholerae Inaba agglutinating serum
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific