Alerta De Seguridad para BD MAX MRSA Assay

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

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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: bd max mrsa assay medical device manufacturer, bd diagnostic systems, has issued a medical device safety alert concerning its bd max mrsa assay [catalogue no.: 442953; unit: 24 each; lot no.: all lots with an expiration date of 2014-01-21 or later]. according to the manufacturer, their investigation of incorrect results related to the college of american pathologists (cap) surveys mrs5-a 2014 and mrs5-b 2014 using the bd-max mrsa assay confirmed that one of the samples for each of the surveys yielded some false positive results. initial analytical testing has demonstrated previously unobserved cross-reactivity due to non-specific binding with certain methicillin-sensitive staphylococcus aureus (mssa) strains, primarily when these organisms are present at high loads (> 1 x 106 cfu/swab). based on the manufacturer’s assessment of the likelihood of a false positive result, as well as documented performance at customer sites, the assay continues to meet clinical performance claims. while there is the potential for a false positive result for specimens from patients who are positive for certain strains of mssa when present at high loads, the manufacturer believes that such an occurrence is unlikely and overall clinical performance would not be affected. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 01 aug 2014.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: BD MAX MRSA Assay
  • Manufacturer