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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Sofia Influenza A + B FIA, Kit #20218		see related information
Date Posted February 14, 2013
Recall Number Z-0819-2013
Product Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
Code Information Lot # Range: 208228-214385, 707916-708108 (29 lots).
Recalling Firm/
Manufacturer		 Quidel Corporation
10165 Mckellar Ct
San Diego, California 92121-4201
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.
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
 
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