Events

Recall of IMMULITE 2000 SYSTEM - CEA 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
    51871
  • Event Risk Class
    III
  • Event Initiated Date
    2014-12-29
  • 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 internal investigation confirmed that the immulite/immulite 1000 and the immulite 2000/ 2000 xpi cea assay does not meet the (within-run precision specifications as per the immulite/immulite 1000 and the immulite 2000/2000 xpi ifu's for all in date immulite cea kit lots. the immulite/immulite 1000 and the immulite 2000/2000 xpi cea inter-assay (total precision) shows equivalence to the ifu and is therefore not impacted by this issue.

Device

IMMULITE 2000 SYSTEM - CEA ASSAY
  • Model / Serial
    Model Catalog: L2KCE6 (Lot serial: ALL CURRENT); Model Catalog: L2KCE2 (Lot serial: ALL CURRENT); Model Catalog: LKCE1 (Lot serial: ALL CURRENT)
  • Product Description
    IMMULITE 2000 SYSTEM-CEA ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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