Events

Field Safety Notices about ScreenLys 2

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

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
  • Date
    2016-04-28
  • Event Date Posted
    2016-05-23
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2016/05/23/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-screenlys-2-hematologija-krvne-grupe-lot-18000-i-19000/
  • 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
    Following complaints from users concerning "false" positive test results for the detection of irregular anti-erythrocyte antibodies when using the "screenlys 2" (ref. 79483) set from lots (lots) 18000 and 19000 (respectively 1236 and 3924 microplates), the manufacturer carried out a survey and determined the cause of this reaction. specifically, within some crosslys recesses in microplates that are part of the screenlys 2 set, there is a problem that will cause a "false" positive result on the presence of antibodies. no "false" negative results have been identified.

Device

ScreenLys 2
  • Model / Serial
    18000 19000
  • Manufacturer
    DIAGAST

Manufacturer

DIAGAST