Class 2 Device Recall QuickVue OneStep hCG Urine

• Date Initiated by Firm: November 23, 2010
• Date Posted: March 01, 2011
• Recall Status: Terminated on June 26, 2012
• Recall Number: Z-1457-2011
• Recall Event ID: 57402
• 510(K)Number: K020799
• Product Classification: Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
• Product: QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842
• Code Information: Lot Number: 706842
• Recalling Firm/ Manufacturer: Quidel Corporation; 10165 Mckellar Ct; San Diego CA 92121-4201
• For Additional Information Contact: John D. Tamerius, Ph.D.; 858-552-7909
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Pending
• 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.
• Quantity in Commerce: 3624 kits = 90,600 tests total
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JHI