Events

Alerte De Sécurité sur API LISTERIA 10STRIPS+10MEDIA

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
    2014-10-06
  • Date de publication de l'événement
    2014-10-06
  • 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_20141006.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 api listeria 10strips+10media medical device manufacturer, biomerieux, has issued a field safety notice concerning api listeria 10strips+10media with reference number 10300 and lot number 1003256440. the manufacturer’s internal investigation identified that the toxic logo label (skull sticker) is absent from the secondary packaging of the api listeria 10strips+10media kit (ref 10300), lot. 1003256440. the indication of toxic product is written, however the symbol that represents “toxic product” indication is absent from the label of the secondary packaging. all components of the affected kit are correctly labeled on their primary packaging, in particular the zym b reagent ampules which are considered a toxic product. the instructions for use located inside the kit also specifies a toxic product is inside the box, and includes rules in terms of protective equipment in order handle the toxic product. the manufacturer defined the described issue as a minor overall risk to health for use in medical bacteriology or in industry bacteriology. the referenced issue does not present a risk to health or safety for patients or users of the product. when using the affected products, users are advised to be aware of the toxic product located in the kit and refer to the instructions for use when handling the associated toxic products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 6 october 2014.

Device

API LISTERIA 10STRIPS+10MEDIA
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biomerieux API LISTERIA 10STRIPS+10MEDIA
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux