Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Fresenius Homecare Brasil Ltda.; DIAGAST.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1818
  • Date
    2016-02-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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