Events

Recall of THYROID TRANSCRIPTION FACTOR-1 ANTIBODY LYOPHILISED MOUSE MONOCLONAL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA MICROSYSTEMS CANADA.

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
    18824
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-10
  • 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
    Leica received a complaint from a customer regarding bond rtu ttf-1 (product code pa0364) giving positive staining on thymoma tissue which was thought to be negative. the ttf-1 antigen had previously been characterised as staining thyroid and lung tumours only and this is the claim made on the instruction for use (ifu). our investigations following this complaint have demonstrated that ttf-1 has a wider expression than was originally thought.

Device

THYROID TRANSCRIPTION FACTOR-1 ANTIBODY LYOPHILISED MOUSE MONOCLONAL
  • Model / Serial
    Model Catalog: NCL-TTF-1 (Lot serial: 136439); Model Catalog: NCL-TTF-1 (Lot serial: 136442); Model Catalog: NCL-TTF-1 (Lot serial: 136441S); Model Catalog: NCL-TTF-1 (Lot serial: 136447); Model Catalog: NCL-TTF-1 (Lot serial: 6000563); Model Catalog: NCL-TTF-1 (Lot serial: 6004009); Model Catalog: NCL-L-TTF-1 (Lot serial: L136443); Model Catalog: NCL-L-TTF-1 (Lot serial: L136446); Model Catalog: NCL-L-TTF-1 (Lot serial: 6000568); Model Catalog: NCL-L-TTF-1 (Lot serial: 6002638); Model Catalog: NCL-L-TTF-1 (Lot serial: L136434); Model Catalog: NCL-L-TTF-1 (Lot serial: L136437); Model Catalog: PA0364 (Lot serial: 05918); Model Catalog: PA0364 (Lot serial: 06912); Model Catalog: PA0364 (Lot serial: 07104); Model Catalog: PA0364 (Lot serial: 08679); Model Catalog: PA0364 (Lot serial: 10903); Model Catalog: PA0364 (Lot serial: 10480)
  • Product Description
    TTF-1 PRIMARY ANTIBODIES
  • Manufacturer
    LEICA MICROSYSTEMS CANADA

Manufacturer

LEICA MICROSYSTEMS CANADA