Safety Alert for AXSYM AFP REAGENTS - Reg. No. 10055310293, list no. 7A48-22

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL LTDA.

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Check if you received communication from 16.07.2003 of ABBOTT LABORATORIES DO BRASIL LTDA, if you have not received contact ABBOTT LABORATORIES DO BRASIL LTDA, by telephone 11 5367000 or your local representative.
  • Reason
    Elevation of afp values ​​by up to 30.5% when compared to manual dilution. these abnormalities are seen only in samples of amniotic fluid and serum samples, which are high enough to require a 1: 101 dilution (values ​​above 350 ng / ml). laboratories calculate the median multiples (mom) and the results for maternal tests are compared with these moms. according to the axsym afp assay usage instructions, it is important for each laboratory to calculate its own moms since they deal with different population. a new version of axsym afp assay software is being developed to provide the automatic dilution protocol 1: 101, on the axsym instrument.
  • Action
    All AxSYM AFP Reagents customers will be informed not to use the 1: 101 automatic dilution protocol.