Events

Recall of Device Recall QuickVue OneStep hCG Urine

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Quidel Corporation.

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
    57402
  • Event Risk Class
    Class 2
  • Event Number
    Z-1457-2011
  • Event Initiated Date
    2010-11-23
  • Event Date Posted
    2011-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96051
  • 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
    Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
  • Reason
    The recall was initiated after quidel corporation determined that a small number of quickvue one-step hcg urine kits have been incorrectly packaged with quickvue h. pylori gll cassettes inside the kit boxes. these foil pouches and test cassettes are clearly labeled as h. pylori. nevertheless, there is a risk that customers may overlook this labeling.
  • Action
    Quidel Corporation initiated an "Urgent Medical Device Recall" letter on November 23, 2010, with an attached "Distributor Recall Notification Form" to the affected distributor consignees notifying them of this issue and requesting return of all kits from the affected lot. Quidel is further requesting that distributor consignees notify end-users of the issue and request return of kit boxes containing the H. pylori pouched cassettes. The recall notices sent to the distributors were sent via US Postal, certified, with return receipt. The consignees were instructed to: (1) Locate kits with the affected lot number and immediately remove the kits from your existing inventory and place them into a quarantine location, (2) Contact Quidel Corporation for instructions on how to return the kits and obtain replacement product. Quidel Technical Support (800) 874-1517, Monday-Friday, 7am - 5pm PST, (3) Fax the enclosed Inventory Form to Quidel at (858) 431-3522. Indicate the total number of kits currently on hand with lot number 706842 or if you do not have any kits of this lot number remaining in inventory.

Device

Device Recall QuickVue OneStep hCG Urine
  • Model / Serial
    Lot Number: 706842
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, HI, IL, KS, KY, MA, MD, MN, NC, NJ, NM, NV, OK, OR, PA, TN, TX, UT, VA, and WA and Canada.
  • Product Description
    QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842
  • Manufacturer
    Quidel Corporation

Manufacturer

Quidel Corporation
  • Manufacturer Address
    Quidel Corporation, 10165 Mckellar Ct, San Diego CA 92121-4201
  • Manufacturer Parent Company (2017)
    Quantimetrix Corporation
  • Source
    USFDA