Z-1231-2017Class II

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

Name: Z-1231-2017 Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25...
Creator: Quidel Corporation
Published: 2017-01-25
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-01-25 / Terminated / root cause: packaging

FDA source

Quidel Corporation began a recall of Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry... on 2017-01-25. FDA classified it as Class II and gives the reason as "Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1231-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-25
Posted: 2017-02-22
Terminated: 2017-06-02
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: 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
Product code: OCC Respiratory Virus Panel Nucleic Acid Assay System
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.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
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.
Quantity in commerce: 1,010 packages
Distribution: Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX
Product codes and lots: PS10171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1231-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1231-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22

Product code OCC

K141520Class IIAlere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. / cleared 2014-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)