Device Recall Influenza Transport Swab 의 리콜

Recall

76337

Class 2

Z-1231-2017

2017-01-25

2017-02-22

Terminated

United States

2017-06-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152840

Quidel corporation is recalling influenza transport swab packages because it may include an incorrect sample swab mixed in with the proper swabs.

Quidel sent an Urgent Medical Device Recall letter dated 1/25/17 to all affected customers and distributors to inform them that Quidel is recalling the Influenza Transport Swab Packages because they may contain incorrect sample swab mixed in with the proper swabs. The letter informs the customers that the standard influenza swab is packaged individually, one (1) swab per package and uses a polyurethane foam tip. The incorrect swab is packaged as two (2) swabs per individual package and uses a rayon fiber tip. Customers are instructed to complete the enclosed Inventory Assessment/Certificate of Destruction form and return to Quidel. Contact Quidel Technical Support at technicalsupport@quidel.com or by calling 800.874.1517 (in the U.S.), or 858.552.1100 (outside the U.S.), for instructions on how to obtain replacement product. Our hours of operation are Monday through Friday, 7:00 a.m. to 5:00 p.m. Pacific Time.