Events

Recall of IMMULITE 1000 SYSTEM - FREE T3 ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS 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
    18636
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-04
  • 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
    It was found that there was a positive shift >10% at the upper limit of the normal reference range for the immulite systems free t3 method as the values do not align with the patient clinical picture when interpreted with other thyroid markers.

Device

IMMULITE 1000 SYSTEM - FREE T3 ASSAY
  • Model / Serial
    Model Catalog: LKF31 (Lot serial: 353); Model Catalog: LKF31 (Lot serial: 354); Model Catalog: L2KF36 (Lot serial: 743); Model Catalog: L2KF32 (Lot serial: 743); Model Catalog: L2KF36 (Lot serial: 742); Model Catalog: L2KF32 (Lot serial: 742); Model Catalog: L2KF36 (Lot serial: 741); Model Catalog: L2KF32 (Lot serial: 741); Model Catalog: L2KF32 (Lot serial: 737); Model Catalog: L2KF32 (Lot serial: 740); Model Catalog: L2KF36 (Lot serial: 739); Model Catalog: L2KF32 (Lot serial: 739); Model Catalog: L2KF36 (Lot serial: 738); Model Catalog: L2KF32 (Lot serial: 738); Model Catalog: L2KF36 (Lot serial: 737); Model Catalog: L2KF36 (Lot serial: 740)
  • Product Description
    IMMULITE 100 SYSTEM - FREE T3 ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED
  • Manufacturer Address
    LLANBERIS
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC