Z-1457-2011

QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842

Name: Z-1457-2011 QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842
Creator: Quidel Corporation
Published: 2010-11-23
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2010-11-23 / Terminated / root cause: labeling and UDI

FDA source

Quidel Corporation began a recall of QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842 on 2010-11-23. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1457-2011
Status: Terminated
Initiated: 2010-11-23
Posted: 2011-03-01
Terminated: 2012-06-26
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
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.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: Lot Number: 706842

Product code JHI

K020799Class IIQuickvue One-Step Hcg-UrineQuidel Corp. / cleared 2002-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)