Events

Alerte De Sécurité sur BD BBL Crystal Enteric/Nonfermenter ID Kit

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par BD Diagnostic 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
    2012-12-28
  • Date de publication de l'événement
    2012-12-28
  • 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_20121228.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: bd bbl crystal enteric/nonfermenter id kit medical device manufacturer, bd diagnostic systems, has issued a medical device safety alert concerning bbl crystal enteric/nonfermenter id kit. the affected catalogue number is 245000 and the affected lot numbers are 2086315, 2101435, 2104316, 2129460, 2129487, 2163211, 2163213, and 2163215. bd has determined through complaint investigation that the above referenced products have the citrate (cit) and malonic acid (mlo) reagents in the reversed prong/well positions. this may lead to no-identification or multiple identification choices. customers specifically reported split identification results between citrobacter and salmonella; however, other bacterial identifications requiring the use of these two substrates may also be affected. according to the local supplier, the affected products have been distributed in hong kong. bd advised the affected customers to discontinue use of the affected lots and discard any remaining packages. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 december 2012.

Device

BD BBL Crystal Enteric/Nonfermenter ID Kit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BD BBL Crystal Enteric/Nonfermenter ID Kit
  • Manufacturer
    BD Diagnostic Systems

Manufacturer

BD Diagnostic Systems