Events

Safety Alert for Enzygnost® Anti-VZV / IgG - Registration number: 10345161685 - Risk class II (Products of medium risk to the individual and / or low risk to public health, subject to registration) - Lots: 44218; 44309; 44565; 45077.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS 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
    1695
  • Date
    2015-10-22
  • 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 discontinuing the use of the Enzygnost Anti-VZV / IgG product.
  • Reason
    Lots 44309; 44565; 45077 of the enzygnost anti-vzv / igg product may exhibit a greater variation of homogeneity. this can lead to invalid races because they do not meet the p / n reference validation criteria at the beginning and end of the series. this issue may lead to an underestimation of the immunity status measured by the titration levels as the absorbance values ​​of samples with falsely low results. the risk of false negative results is unlikely but can not be totally excluded. when monitoring a potential infection by changing the title level over time with repeated design, the variance of the levels may be higher than expected. in rare cases, this can lead to a title change.
  • Action
    The company that holds the registration is promoting the "Discontinuation of use" of the product. (Attached Letter to Clients). PI Code 15-019.

Device

Enzygnost® Anti-VZV / IgG - Registration number: 10345161685 - Risk class II (Products of medium ...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA