Events

Safety Alert for Technical Name: TOXOPLASMA GONDII Registration Number ANVISA: 80146501651 Hazard Class: III Affected Model: Not applicable Serial Numbers Affected: 64245LI00; 66063LI00; 67003LI00; 68443LI00; 69252LI00; 70171LI00; 66066LI00; 67006LI00; 68444LI00; 69253LI00 and 70174LI00.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil; Inpeco S.A..

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
    2162
  • Date
    2016-12-13
  • 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
    Review this release with your Medical Director. Additional tests with a secondary method are recommended to confirm the reactive results (= 0.60 Index or = 1.00 S / CO) for samples from immunocompromised or newborn infants or umbilical cord blood samples and other samples with expected low concentrations of IgM . Keep this notice in your lab files
  • Reason
    For the architect toxo igm assay, an increase in false gray and / or reactive zone results was observed for samples from immunocompromised or newborn patients, as well as umbilical cord blood samples with batches indicated above. these types of samples have a low total igm titer in common. internal studies with the architect toxo igm assay have demonstrated that samples from pregnant women and serum and plasma samples from blood donors are not impacted and meet the specificity specifications of the assay. abbott has identified a solution to the problem and plans a product modification for the first quarter of 2017.
  • Action
    Field Action Code FA14NOV2016 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

Technical Name: TOXOPLASMA GONDII Registration Number ANVISA: 80146501651 Hazard Class: III Affec...

Manufacturer

Abbott Laboratórios do Brasil; Inpeco S.A.
  • Source
    ANVSANVISA