Events

Recall of IMMULITE SYSTEM - PROGESTERONE ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    15472
  • Event Risk Class
    II
  • Event Initiated Date
    2017-01-06
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Siemens has confirmed that the presence of dhea-s (a metabolite of dhea a steroid hormone that may be used as part of in vitro fertilization (ivf) protocols to improve ovarian response and ivf treatment outcomes) causes falsely elevated progesterone results on the advia centaur dimension vista and immulite systems around the clinically important decision level of approximately 1 ng/ml (3.18 nmol/l) of progesterone. this threshold is used by some ivf protocols to determine whether to proceed with fresh embryo transfer in the current cycle.

Device

IMMULITE SYSTEM - PROGESTERONE ASSAY
  • Model / Serial
    Model Catalog: LKPW1 (Lot serial: ALL LOTS); Model Catalog: L2KPW6 (Lot serial: ALL LOTS); Model Catalog: L2KPW2 (Lot serial: ALL LOTS)
  • Product Description
    IMMULITE SYSTEM-PROGESTERONE ASSAY;IMMULITE 100 SYSTEM-PROGESTERONE ASSAY;IMMULITE 2000 SYSTEM-PROGESTERONE ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC