Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests
This recall has been terminated (originally issued February 22, 2017).
- Company
- Quidel Corporation
- Recall Initiated
- January 25, 2017
- Posted
- February 22, 2017
- Terminated
- June 2, 2017
- Recall Number
- Z-1231-2017
- Quantity
- 1,010 packages
- Firm Location
- San Diego, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.
Distribution
Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX
Lot / Code Info
PS10171
Root Cause
Mixed-up of materials/components
Action Taken
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.