Events

Field Safety Notices about ADVIA Centaur®, Dimension Vista®, IMMULITE®

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 d.o.o..

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 confirmed that the presence of dhea-s, the metabolite of the steroid hormone dhea used in the in vitro fertilization (ivf) process to improve the ovarian response and thus better in vitro fertilization results in a clinical decision-making concentration range of 1 ng / ml (3.18 nmol / l) of falsely elevated progesterone measured by the progesterone assay tests listed in table 1.

Device

ADVIA Centaur®, Dimension Vista®, IMMULITE®
  • Model / Serial
    ADVIA Centaur Progesterone1 PRGE 10310305 10315522 10333111 10310305 10315522 10333111 All lot numbers Dimension Vista LOCI Progesterone2 PROG K6464 10461743 All lot numbers IMMULITE / IMMULITE 1000 Progesterone PRG LKPW1 10381128 All lot numbers IMMULITE 2000 Progesterone3 PRG L2KPW2 L2KPW6 10381181 10381170 All lot numbers
  • Manufacturer
    Siemens Healthcare d.o.o.

Manufacturer

Siemens Healthcare d.o.o.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    AMPMDRS