Events

Field Safety Notices about ACCESS hLH 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
    2012-11-19
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2012/11/19/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-access-hlh-calibrators/
  • 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
    The manufacturer has found that for these calibrators, an inappropriate expiration date has been established, so the results obtained when used can be falsely increased by up to 13%. this can happen up to four months before the expiration date.

Device

ACCESS hLH Calibrators
  • Model / Serial
    33515 - lot 220438, 122157, 118299, 113689, 109784, 022519, 014099, 011895, 008546, 916872.
  • Manufacturer
    Beckman Coulter, Inc

Manufacturer

Beckman Coulter, Inc