Events

Alerta De Seguridad para DUOLYS, IMUNOHEMATOLOGY - ABO - MONOCLONAL ORIGIN, record 10154450118, model: 12 DuoLys microplates for 12 x 8 ABO-RH1 typing and RH-K phenotypes (each microplate contains 8 wells of Anti-A, Anti-B, Anti-A, B , Anti-E, Anti-E, Anti-K, Negative Control and 2 x 8 empty wells) + 1 vial of 40 ml of MagneLys, hazard class IV, lots: PhenoLys for 12 x 16 RH-K phenotypes (each microplate contains 2 x 8 wells of negative control, 2 x 8 negative control wells, Anti-C, Anti-E, Anti-c, Anti-e, Anti-K) + 1 vial of 40 ml MagneLys, hazard class IV, batches: 618000, 619000, 620000.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Fresenius Homecare Brasil Ltda.; DIAGAST.

¿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
  • ID del evento
    1818
  • Fecha
    2016-02-10
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    The Brazilian population is very heterogenous, and some specific population groups have distinct variants of Anti-RH5, which can lead to some false negative results when using the product. As these cases are very rare, it is difficult to identify them, the company in becoming aware of this possibility, is suggesting the use of a complementary method for the identification of this antigen.
  • Causa
    Fresenius kabi has identified a divergence in the results of some samples of the duolys and phenolys products, which are used for phenotyping the rh + k system in laboratories and blood banks in the freelys nano and qwalys equipment. we have noticed that some samples of the product have failed to detect the antigen "e" (one of the antigens that is part of the kit profile). clones of the anti-and impregnated monoclonal reagent in the wells of these microplates are ms63 and p3gd512.
  • Acción
    Availability of a reagent Soroclone Anti-e, of monoclonal origin, for tube testing. Action code: 01-2016. As a preventive measure, the phenotype is repeated for the antigen "e", in all cases where the result obtained in the microplate is negative for said antigen. For this, Fresenius Kabi will be supplying, together with the DuoLys and PhenoLys kits, the monoclonal reagent Soroclone Anti-e, for tube testing, prepared from clones MS26 + MS21 + MS63.

Device

DUOLYS, IMUNOHEMATOLOGY - ABO - MONOCLONAL ORIGIN, record 10154450118, model: 12 DuoLys microplat...

Manufacturer

Fresenius Homecare Brasil Ltda.; DIAGAST