Events

Alerte De Sécurité sur Muller Hinton 2 agar + 5% sheep blood

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
    2016-08-18
  • Date de publication de l'événement
    2016-08-18
  • 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_201608018.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 muller hinton 2 agar + 5% sheep blood medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its muller hinton 2 agar + 5% sheep blood [reference number: 43329, 43321 and 43324]. during an internal investigation, the manufacturer observed that the use of the medium mueller hinton 2 agar + 5% sheep blood (mh-s) (ref. 43329-43321-43324) with the cotrimoxazole antibiotic (= trimethoprime-sulfamethoxazole) (sxt) could lead to false susceptible results for s. pneumonia and streptococci strains with a disc diffusion method whatever is the shelf-life of the media. according to the manufacturer, results for others combinations strains-antibiotics that could be tested on mh-s medium (ref. 43321-43329-43324) are conform to the expected results. results on (mh2-f) (ref. 41864) bottle and mueller hinton 2 agar (mh2-d) (ref. 51075-51860) regarding the sxt antibiotic are conform to the expected results the manufacturer is advising users do not use the affected products with the sxt antibiotic whatever the strain that could be tested. the users can use (mh2-f) (ref. 41864) bottle and mueller hinton 2 agar (mh2-d) (ref. 51075-51860) with 5% sheep blood with the sxt antibiotic as products performed within the specifications. 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 18 august 2016.

Device

Muller Hinton 2 agar + 5% sheep blood
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: BioMerieux Muller Hinton 2 agar + 5% sheep blood
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux