Events

Recall of QUICKSTEP PLUS ONE STEP URINE PREGNANCY TEST

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INNOVATEK MEDICAL 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
    83034
  • Event Risk Class
    III
  • Event Initiated Date
    2013-04-24
  • 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
    One end user has recently reported a random finding of anti-hiv tests inside some of the sealed quickstep plus pouches instead of hcg pregnancy tests. any anti-hiv tests found are not usable on their own and will not give any valid result as they lack other test components necessary to perform a test procedure. affected test cassettes have "anti-hiv" prominently embossed next to the reading window are smaller in size than pregnancy tests have a different configuration and lack the blue colour in the sample well that pregnancy test cassettes show. the expiry date is nearing on this lotand that all quickstep plus pregnancy test kits of lot number 04081 must be discarded after april 30 2013.

Device

QUICKSTEP PLUS ONE STEP URINE PREGNANCY TEST
  • Model / Serial
    Model Catalog: 4220-33 (Lot serial: 04081)
  • Product Description
    Quickstep Plus one step urine pregnancy test
  • Manufacturer
    INNOVATEK MEDICAL INC.

Manufacturer

INNOVATEK MEDICAL INC.