Events

Alerte De Sécurité sur 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.

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 DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH.

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
    1565
  • Date
    2015-04-30
  • 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 company recommends "DISCONTINUE USING THE PRODUCT".
  • Cause
    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 ".
  • Action
    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