Recall Z-1457-2011 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Quidel Corporation
QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842
| Date | Mar 1, 2011 (initiated Nov 23, 2010) |
| Status | Terminated |
| 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. |
| 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 af |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020799 | QUICKVUE ONE-STEP HCG-URINE Quidel Corp., May 17, 2002 |