Z-0819-2013Class II

Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic

Name: Z-0819-2013 Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic
Creator: Quidel Corporation
Published: 2012-12-03
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2012-12-03 / Terminated / root cause: manufacturing process

FDA source

Quidel Corporation began a recall of Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic on 2012-12-03. FDA classified it as Class II and gives the reason as "Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0819-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-03
Posted: 2013-02-14
Terminated: 2014-01-31
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Product code: GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Reason for recall: Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Quidel Corporation sent a Medical Device Recall dated December 3, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product and remove the affected product from their inventory. Customers should contact Quide Corporation for instructions on how to obtain replacement product. Customers were instructed to fax the enclosed inventory Form to Quidel at 858-552-7905. For technical support customers should call 800-874-1517 or 858-552-1100. For questions regarding this recall call 858-552-1100, ext 7922.
Quantity in commerce: 13,090 kits (327,250 tests)
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Korea, Norway, Germany, Chile, Hong Kong, Switzerland, Netherlands, Thailand, Japan, China, and the UK
Product codes and lots: Lot # Range: 208228-214385, 707916-708108 (29 lots).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0819-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0819-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-14

Product code GNX

K112177Class IISofia Analyzer and Influenza A+b FiaQuidel Corp. / cleared 2011-10-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)