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U.S. Department of Health and Human Services

Class 2 Device Recall Influenza Transport Swab

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 Class 2 Device Recall Influenza Transport Swabsee related information
Date Initiated by FirmJanuary 25, 2017
Date PostedFebruary 22, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall NumberZ-1231-2017
Recall Event ID 76337
510(K)NumberK141520 
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
ProductInfluenza 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
Code Information PS10171
Recalling Firm/
Manufacturer		 Quidel Corporation
10165 McKellar Ct
San Diego CA 92121-4201
For Additional Information Contact
858-552-1100 Ext. 7922
Manufacturer 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.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionQuidel 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 technicalsupport@quidel.com 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 Commerce1,010 packages
DistributionNationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OCC
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