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U.S. Department of Health and Human Services

Class 2 Device Recall Sofia Influenza A B FIA, Kit 20218

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 Class 2 Recall
Sofia Influenza A B FIA, Kit 20218
see related information
Date Posted February 14, 2013
Recall Status1 Terminated on January 31, 2014
Recall Number Z-0819-2013
Recall Event ID 64017
Premarket Notification
510(K) Number
K112177 
Product Classification Antigens, Cf (Including Cf Control), Influenza Virus A, B, C - Product Code GNX
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
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GNX and Original Applicant = QUIDEL CORP.
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