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 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
  • Date
    2016-11-24
  • 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 is conducting a recall for the immulite® 2000/immulite® 2000 xpi intact pth (intact parathyroid hormone) (ipth) assay kit lot 320. siemens has confirmed that immulite® 2000/immulite® 2000xpi intact pth kit lot 320 listed in table 1 can exhibit an average negative bias of up to -39% at ipth concentrations <20 pg/ml with serum and edta patient samples vs. a reference kit lot. .

Device

IMMULITE® 2000 IMMULITE® 2000 XPi

Manufacturer

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