Events

Alerta De Seguridad para Product Name: Family Reagents for Immunohematology -Complementary Reagents- DIAMED //// Model: ID-DAT IgG - DILUTION - 004033 - Record Number: 80004040133 - Hazard Class: II - Lots: ID-DAT IgG - Dilution (REF 004033 ) Lot 50870.29.02 and ID-DAT IgG-Dilution (REF 004033) Lot 50870.30.01.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH.

¿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
    1565
  • Fecha
    2015-04-30
  • 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 company recommends "DISCONTINUE USING THE PRODUCT".
  • Causa
    Dilution (ref 004033) batch 50870.29.02 and id-dat igg - dilution (ref 004033) batch 50870.30. dilution of product reactivity, identified by means of the monitoring of the stability performed in samples of retention of id-dat igg. 01. according to the company, "the division mentioned can affect the evaluation of the hemolysis risk in the following situations: • monitoring the patient with hemolytic anemia auto-imune (aiha) • monitoring hemolytic disease in newborns • other investigations for dat positives considering used laboratory practices and the intended use of this product, the results obtained from this product should not be considered isolately but associated with the patient's clinical condition, his medical history, in addition to other relevant laboratory data. in the instruction for use accompanying the product ".
  • Acción
    The company is communicating its clients (IN THE ANNEX LETTER TO THE CLIENTS AND MAP OF DISTRIBUTION) and carrying out the Recolhimento for the destruction of the lots under risk in Brazil. Code: AC 2015/01

Device

Product Name: Family Reagents for Immunohematology -Complementary Reagents- DIAMED //// Model: ID...

Manufacturer

DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH