Events

Alerta De Seguridad para Muller Hinton 2 agar + 5% sheep blood

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por BioMerieux.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-08-18
  • Fecha de publicación del evento
    2016-08-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_201608018.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BioMerieux Muller Hinton 2 agar + 5% sheep blood
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux