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
    64415
  • Event Risk Class
    III
  • Event Initiated Date
    2014-03-24
  • 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 healthcare diagnostics has confirmed that the intra-assay and inter-assay precision of the immulite/immulite 1000 and immulite immulite 2000 xpi anti-tg ab assays does not align with the representative data published in the instructions for use (ifu). siemens has conducted a "verification of precision performance" study to assess precision. while the concentrations did not exactly match those published in the ifu the study provides verification that the current precision performance is not in line with the ifu.

Device

IMMULITE SYSTEM - ANTI-TG AB
  • Model / Serial
    Model Catalog: LKTG1 (Lot serial: 244); Model Catalog: L2KTG6 (Lot serial: 567); Model Catalog: L2KTG2 (Lot serial: 567); Model Catalog: L2KTG6 (Lot serial: 565); Model Catalog: L2KTG2 (Lot serial: 565); Model Catalog: L2KTG6 (Lot serial: 560); Model Catalog: L2KTG2 (Lot serial: 560); Model Catalog: L2KTG6 (Lot serial: 577); Model Catalog: L2KTG2 (Lot serial: 577); Model Catalog: L2KTG6 (Lot serial: 574); Model Catalog: L2KTG2 (Lot serial: 574); Model Catalog: L2KTG6 (Lot serial: 572); Model Catalog: L2KTG2 (Lot serial: 572); Model Catalog: L2KTG6 (Lot serial: 569); Model Catalog: L2KTG2 (Lot serial: 569); Model Catalog: L2KTG6 (Lot serial: 562); Model Catalog: L2KTG2 (Lot serial: 562); Model Catalog: L2KTG6 (Lot serial: 566); Model Catalog: L2KTG2 (Lot serial: 566); Model Catalog: L2KTG6 (Lot serial: 564); Model Catalog: L2KTG2 (Lot serial: 564); Model Catalog: LKTG1 (Lot serial: 245)
  • Product Description
    Immulite System-Anti-TG AB
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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