Recall of Device Recall OvuChek

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Quest Products 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
    52901
  • Event Risk Class
    Class 2
  • Event Number
    Z-0968-2010
  • Event Initiated Date
    2008-11-07
  • Event Date Posted
    2010-03-03
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2010-03-03
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Test, luteinizing hormone (1h), over the counter - Product Code NGE
  • Reason
    The ovulation test strips were shipped without 510(k) premarket notification clearance from the fda.
  • Action
    Quest Products notified their major customer by telephone and e-mail on 11/7/08, requesting the return of all inventory of the OvuChek Saliva Ovulation Test Strips due to a lack of 510(k) clearance for marketing of the device.

Device

  • Model / Serial
    UPC 8 50877 00055 5, all lots
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch, packaged in a box with a specimen cup and instructions for use, 12 boxes per case; a rapid colorimetric indicator for the qualitative changes (ferning) of salt content in saliva to aid in the prediction of ovulation; Distributed by Quest Products, Libertyville, IL || A rapid saliva indicator for the qualitative prediction of favorable and unfavorable fertile days in women's menstrual cycles.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Quest Products Inc., 14052 W Petronella Dr Ste 103, Libertyville IL 60048-9512
  • Source
    USFDA