Safety Alert for PROLATIN KIT OF AxSYM and IMx - PROLACTIN CALIBRATES Reg. No. 10055311055 n ° list 9C07-01 - Lots 75255Q100, 78013Q100, 79026Q100 and 80697Q100 - PROLACTIN CONTROLS Reg. No. 10055311058 n ° list 9c07-10, lot 77575Q100, 78753Q100, 80284Q100 and 81124Q100 - AxSYM PROLACTIN MASTER CALIBRATES Reg. No. 10055311055, list no. 7A62-32, lot 7556Q100, 78020Q100, 79027Q100, 80584Q100 and 83668Q100 - IMx PROLACTIN REAGENTS Reg. No. 10055310228, list no. 2244-22, lot no 78752Q100 and no. 80548Q100

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 telephone 11 5367000 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
    Test determined that the prolactin concentration in axsym batches mastes calibrators, prolactin calibrators, prolactin controls and imx mode 1 may have decreased by approximately 20%. imx mode 1 is a component of the imx reagent kit. decreased prolactin concentration in the calibrators may cause a change in the values ​​of the controls and a rise in patient outcomes. this change can be observed with abbott controls and multi-constituent controls from other manufacturers. there is a possibility that patient outcomes may have been elevated by approximately 20%.
  • Action
    Collection and segregation for dissolution. Batches 75255Q100, 7813Q100, 75256Q100 and 78020Q100 have expired. A customer communication letter has been sent to all AxSYM and IMx customers who received the lots distributed in Brazil. Expiration dates for future batches of calibrators and controls will be redetermined to ensure acceptable product performance until the expiration date of the Material. Research to determine the cause of this decrease in concentration is under way.