Events

Recall of IMMULITE SYSTEM - ANTI-TG AB

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
    68876
  • Event Risk Class
    III
  • Event Initiated Date
    2017-06-22
  • 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 immulite systems anti-tg ab calibration verification material (cvm) lot 102 levels cvm2 through cvm4 catalog ltgcvm is recovering high outside of the published +/- 2sd guideline ranges in the ifu. this issue applies to use with the immulite 2000 and immulite 2000 xpi anti-tg ab assay only.

Device

IMMULITE SYSTEM - ANTI-TG AB
  • Model / Serial
    Model Catalog: LTGCVM (Lot serial: 102)
  • Product Description
    IMMULITE SYSTEM - ANTI-TG AB;IMMULITE 1000 SYSTEM - ANTI-TG AB
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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