Events

Recall of IMMULITE SYSTEM - THYROGLOBULIN 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
    15451
  • Event Risk Class
    III
  • Event Initiated Date
    2017-12-18
  • 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 through internal investigation that the immulite/immulite 1000/immulite 2000/immulite 2000 xpi assays listed in the above table are susceptible to biotin interference. this occurs when biotin present in patient samples interferes with the biotin-streptavidin assay architecture on the immulite platform. biotin interference has the potential to bias analytical results on the assays listed above. the instructions for use (ifu) currently do not list biotin as a potential interferant.

Device

IMMULITE SYSTEM - THYROGLOBULIN ASSAY
  • Model / Serial
    Model Catalog: LKTY1 (Lot serial: N/A); Model Catalog: LKCE1 (Lot serial: N/A); Model Catalog: L2KUN6 (Lot serial: N/A); Model Catalog: L2KFO6 (Lot serial: N/A); Model Catalog: L2KFO2 (Lot serial: N/A); Model Catalog: LKBR1 (Lot serial: N/A); Model Catalog: LKEPN1 (Lot serial: N/A); Model Catalog: L2KGA2 (Lot serial: N/A); Model Catalog: LKMB1 (Lot serial: N/A); Model Catalog: L2KOP2 (Lot serial: N/A); Model Catalog: L2KBR2 (Lot serial: N/A); Model Catalog: LKGA1 (Lot serial: N/A); Model Catalog: L2KMB2 (Lot serial: N/A); Model Catalog: LKVB1 (Lot serial: N/A); Model Catalog: L2KEPN6 (Lot serial: N/A); Model Catalog: LKOP1 (Lot serial: N/A); Model Catalog: L2KHC2 (Lot serial: N/A); Model Catalog: L2KCE2 (Lot serial: N/A); Model Catalog: L2KCE6 (Lot serial: N/A); Model Catalog: L2KTY2 (Lot serial: N/A); Model Catalog: L2KEPN2 (Lot serial: N/A)
  • Product Description
    IMMULITE SYSTEM- THYROGLOBULIN ASSAY;IMMULITE SYSTEM- CEA ASSAY;IMMULITE 2000 SYSTEM-3GALLERY SPECIFIC IGE ASSAY;IMMULITE 2000 SYSTEM- FOLIC ACID ASSAY;IMMULITE 1000 SYSTEM- THYROGLOBULIN ASSAY;IMMULITE SYSTEM- BR-MAT. MARKER CA 15.3 ASSAY;IMMULITE SYSTEM
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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