Safety Alert for ALCYON HDL, ANVISA Registration No. 10055310869, LIST 8D42-02, LOTES 85124HW00, 89031HW00 and 92010HW00

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 there are any batches in your stock. If you do, please contact ABBOTT LABORATORIOS DO BRASIL LTDA, by calling 0800-119099 or your local representative, in order to make the return and consequently the replacement of the same. The UTVIG - Technovigilance Unit is monitoring the entire collection, return and replacement process until it closes.
  • Reason
    They may deteriorate before the expiration date. the degradation of the reagent is indicated by the inability to produce acceptable calibrations and / or to recover controls within acceptable limits. in addition, linearity samples in the linearity range of the 180 mg / dl assay may not meet acceptable criteria. if calibrations and controls are within limits, patient outcomes were not affected for the batch numbers mentioned.
  • Action
    Identify whether you are currently using or own stock of the ALCYON HDL Direct Reagent, lots 85124HW00,89031HW00 and 92010HW00 discontinue and store in your lab for later return.