Events

Field Safety Notices about immulite 2000 / immulite 2000 xpi psa test with the number 408

According to Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, this field safety notices involved a device in Poland 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 ID
    506
  • Date
    2016-12-02
  • Event Country
    Poland
  • Event Source
    ORMPMDBP
  • Event Source URL
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-siemens-healthcare-diagnostics-dotycz%C4%85ca-wycofania-z-obrotu-i-3
  • Notes / Alerts
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Extra notes in the data
  • Action
    Siemens Healthcare Diagnostics safety notice regarding the withdrawal and use of the IMMULITE 2000 / IMMULITE 2000 XPi PSA test (catalog number L2KPS2 or L2KPS6) with lot number 408

Device

immulite 2000 / immulite 2000 xpi psa test with the number 408

Manufacturer

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