Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH.

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