Device Recall QuickVue OneStep hCG Urine 의 리콜

Recall

57402

Class 2

Z-1457-2011

2010-11-23

2011-03-01

Terminated

United States

2012-06-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96051

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.

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.