Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Fresenius Homecare Brasil Ltda.; DIAGAST.

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
  • ID de l'événement
    1818
  • Date
    2016-02-10
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Action
    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