Events

Alerte De Sécurité sur FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH

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
    2014-03-11
  • Date de publication de l'événement
    2014-03-11
  • 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_20140311.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 fb (fast blue bb), zym b reagent, api listeria, and api nh medical device manufacturer, biomerieux, has issued a field safety notice (fsn) concerning certain lots of biomerieux fb (fast blue bb) with reference number 70562, zym b reagent with reference number 70493, api listeria with reference number 10300, and api nh with reference number 10400. identification strips using the fb reagent: api campy (20800), id 32 staph (32500), rapid id 32a (32300), rapid id 32 strep (32600) identification strips using the zym b reagent: api 20 strep (20600), api coryne (20900), api staph (20500), api zym (25200), api nh (10400), api listeria (10300) the issue may result in misidentification of microorganisms. the manufacturer advises users of the followings: if users are in possession of some kits of fb reagent (70562), they should implement the mandatory requirements as mentioned in the fsn. if users are in possession of some kits of zym b (70493), api nh (10400) and api listeria (10300), they should check the aspect of zym b (70493) before each use and follow the recommendations mentioned in the fsn. users should discuss with the laboratory director to evaluate the impact and determine if any retrospective analysis of results is required. for the next batches, an insert will be added in fb reagent (70562), zym b (70493), api nh (10400) and api listeria (10300) to explain the mandatory actions required in this fsn. 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 11 march 2014.

Device

FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biomerieux FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux