Events

Safety Alert for Family of Hematology Reagents for Immunohematology - Record 10154450145 - Affected Lot: 71FG20EA

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by FRESENIUS HEMOCARE BRASIL LTDA.

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
    1154
  • Date
    2012-07-26
  • 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 product is used in antibody screening tests in donor / patient serum or plasma. If it is positive, it should be complemented by further testing with the reagent Blood Cell Panel to identify the antibody present. Due to this need to identify antibodies or to reconcile blood components in case of transfusion, the risk is attenuated for patients. Anvisa accompanies this Action.
  • Reason
    The triacel ii product presents negative phenotyping for the fya antigen, and the accompanying diagram showed positive phenotyping for the antigen (see annex) http://portal.Anvisa.Gov.Br/wps/wcm/connect/b11bbf004c1e184599b9d9dc39d59d3e/ letter_ao_cliente_1154.Pdf? mod = ajperes.
  • Action
    Check new Diagram forwarded by the company.

Device

Family of Hematology Reagents for Immunohematology - Record 10154450145 - Affected Lot: 71FG20EA

Manufacturer

FRESENIUS HEMOCARE BRASIL LTDA