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Terminated

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

FDA Recall Z-1231-2017 · Posted 2017-02-22

Recalling FirmQuidel Corporation
Recall StatusTerminated
Product CodeOCC
Date Initiated2017-01-25
Date Terminated2017-06-02
Product Quantity1,010 packages

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.

Firm Action

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 [email protected] 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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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