Events

Alerta De Seguridad para VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards

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
    2018-08-24
  • Fecha de publicación del evento
    2018-08-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180824a.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 vitek 2 gram positive antimicrobial susceptibility testing (ast) cards the united states food and drug administration (fda) has issued a medical device safety alert concerning vitek 2 gram positive cefoxitin screen and vitek 2 gram positive ast for oxacillin [lot numbers: all lots of gram positive ast cards with oxacillin and cefoxitin tests; manufacturing and distribution dates: 8 february 2017 to present], manufactured by biomerieux. the manufacturer is recalling the affected products because of false negative or false susceptible results for some strains of methicillin-resistant staphylococcus aureus (mrsa). it is continuing to investigate the issue to determine the root cause of the failure and the prevalence of the strains that are subject to erroneous results. according to the manufacturer, missed diagnosis and inappropriate treatment of mrsa could cause severe health consequences, including lack of treatment for a mrsa infection, and death. the manufacturer recommends that labs confirm potential mrsa upon activation of the software bioart rule. the mrsa safety alert letter is issued directing labs to: implement a custom vitek 2 system software bioart rule to aid in mitigating potential non-detection of mrsa when testing oxacillin (ox) and cefoxitin screen (oxsf) on vitek 2, enable the advanced expert system on the vitek 2 systems software to ensure that the appropriate forcing rules are applied to test results regardless of the parameter set in use, and use the existing strain submission system to send isolates of suspect strains of mrsa to the manufacturer for additional testing. for details, please refer to the following fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm618135.Htm if you are in possession of the products, please contact your supplier for necessary actions. posted on 24 august 2018.

Device

VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards
  • Modelo / Serial
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Descripción del producto
    Medical Device Safety Alert: BioMerieux VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux