Events

Alerte De Sécurité sur Campylosel agar

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

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
    2016-09-06
  • Date de publication de l'événement
    2016-09-06
  • 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_20160906.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: biomerieux campylosel agar medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its campylosel agar [reference number: 43361; lot number: 1004948090, 1004981930 and 1005023880]. based on a lack of selectivity issue reported on plates of the impacted lots of campylosel agar, the manufacturer initiated a complaint investigation to confirm product performance and determine root cause. while the investigation is still ongoing, the following have been identified: there is growth of a enterobacter cloacae strain isolated in a laboratory on the impacted lots of campylosel agar that could mask the growth of the campylobacter strain. this growth could lead to a misinterpretation of the results and therefore to a false negative result. the growth of this enterobacter cloacae strain on the impacted lots of campylosel agar could be explained by higher mic for aztreonam and cefoperazon antibiotics than usually. according to the manufacturer, immediate corrective action was implemented on 5 aug 2016 at the manufacturing site level to optimize campylosel agar manufacturing conditions by reducing the additive shelf-life when used for the manufacturing of campylosel agar. the users are advised to follow the instructions and implemented the actions as indicated in field safety notice according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 september 2016.

Device

Campylosel agar
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BioMerieux Campylosel agar
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux