Events

Alerte De Sécurité sur Etest Ertapenem

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
    2014-02-12
  • Date de publication de l'événement
    2014-02-12
  • 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_20140212.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 etest ertapenem medical device manufacturer, biomerieux, has issued a field safety notice concerning certain lots of the following products: etest ertapenem - foam etp 32 – 30 tests (reference: 531610); etest ertapenem- foam etp 32 – 100 tests (reference: 531618); etest ertapenem etp 32 – single pack of 30 tests (reference: 412332) the manufacturer identified a performance issue on the etest foam ertapenem (reference 531610 and 531618) and etest single pack ertapenem (reference 412332). these strips did not give the correct minimum inhibitory concentration (mic) for some of quality control strains. for non-enterobacteriaceae (quality control purpose), the mic shift over the time can be greater than +1 dilution when compared to the mics initially obtained at the time of the release. for enterobacteriaceae, the over-estimation of mic can change the category result of isolates having mic equal or close to the breakpoint. according to the manufacturer, this performance issue leading to this over-estimation of mic can be detected using the quality control as recommended in the etest package insert. the manufacturer advises users to discontinue using and to destroy the affected kits. it will provide replacement kits as soon as a new batch of etest ertapenem is available. 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 12 february 2014.

Device

Etest Ertapenem
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biomerieux Etest Ertapenem
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux