Events

Field Safety Notices about IMMULITE® 2000 IMMULITE® 2000 XPi

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Siemens Healthcare Diagnostics 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 Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics has confirmed that the immulite 2000®/immulite 2000 xpi® sex hormone binding globulin (shbg) adjustor lots 124 and 125 packed with reagent lots listed in table 1 do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8°c, as published in the instructions for use (ifu). reconstituted adjustors stored at 2-8°c after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. the reagent lots listed below can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg concentrations of 5 nmol/l to 170 nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not concentration dependent. .

Device

IMMULITE® 2000 IMMULITE® 2000 XPi
  • Model / Serial
    IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 357 2017/01/30 2016/03/08 2016/03/11 IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 358 2017/03/31 2016/05/04 2016/05/06 IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 360 2017/04/30 2016/06/13 2016/06/15
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS