Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tube

FDA device recall Z-1231-2017 · posted 2017-02-22 · Terminated

Recall details

Recalling firm

Quidel Corporation

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.

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

OCC

Quantity affected

1,010 packages

Distribution

Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX

Date initiated

2017-01-25

Date posted

2017-02-22

Date terminated

2017-06-02

Location

San Diego, CA

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