Field Safety Notices about ACCESS Folate Calibrators

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Beckman Coulter, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 recall data from the U.S. and Serbia.
  • Extra notes in the data
  • Reason
    As a result of internal company testing, it was confirmed that access folat the calibrator cannot reach stability for 6 months(a98033) or 12 months (a14207), when frozen. these calibrator lots can lead to false elevations that they can mask folate deficiency. day-to-day control can strive for higher values and over time set out laboratory specification. a clinically significant increase in patients' folate levels may occur before control goes beyond the specified range.


  • Model / Serial
    A14207 - lot 112788, 115741, 118917; A98033 - lot 122651, 123635, 219962
  • Manufacturer