Events

Field Safety Notices about IMMULITE 2000 IGF-I, IMMULITE 1000 IGF-I

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 Products Limited.

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
    2012-10-12
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2012/12/10/vazno-obavestenje-o-medicinskom-sredstvu-immulite-2000-igf-i-i-immuliteimmulite-1000-igf-i/
  • 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 noticed a positive deviation in median values (higher scores) in patients (of about 20%) when using the igf-1 test.

Device

IMMULITE 2000 IGF-I, IMMULITE 1000 IGF-I
  • Model / Serial
    441; 442; 443; 444; 445; 446; 447; 448; 449, 450; 451; 452; 455; 456; 457; 458; 459; 460; 461; 462; 463; 464; 465; 466; 467; 468; 469; 470; 471; 472; 473; 474; 475; 476; 477; 478; 479; 480; 481; 481L; 481M; 482; 483; 484; 485; 486; 487; 488; 489; 490; 491; 492; 315; 316; 317; 318; 319; 320; 322; 323; 324; 325; 326; 327; 328; 329; 330; 333; 334
  • Manufacturer
    Siemens Healthcare Diagnostics Products Limited

Manufacturer

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