Events

Recall of OC-LIGHT MANUAL IFOBT KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOMAGEN DIAGNOSTICS INC..

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
    62636
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-04
  • 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
    The test strips in the affected product lots of the oc light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. there may be a possibility of obtaining false negative results when using the affected lots.

Device

OC-LIGHT MANUAL IFOBT KIT
  • Model / Serial
    Model Catalog: FOBSTR (Lot serial: >10 numbers contact mnf); Model Catalog: FOB50 (Lot serial: >10 numbers contact mnf)
  • Product Description
    OC Light Manual iFOBT Kit(FOB50) & Strips(FOBSTR)
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

SOMAGEN DIAGNOSTICS INC.
  • Manufacturer Address
    EDMONTON
  • Manufacturer Parent Company (2017)
    Diploma Plc
  • Source
    HC