Events

Field Safety Notices about IMMULITE 2000 Intact PTH

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

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
    2017-03-02
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2017/03/02/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-immulite-2000-intact-pth/
  • 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
    It was found that the lot kit 320 of the "immulite 2000 intact pth" test can show an average negative deviation of up to 39%, at concentrations of ipth <20 pg / ml, with sera and "edta" patient samples, compared with the reference lot.

Device

IMMULITE 2000 Intact PTH

Manufacturer

Siemens Healthcare Diagnostics
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ALIMSA