Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Influenza Transport Swab

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Influenza Transport Swab see related information
Date Initiated by Firm January 25, 2017
Date Posted February 22, 2017
Recall Status1 Terminated 3 on June 02, 2017
Recall Number Z-1231-2017
Recall Event ID 76337
510(K)Number K141520  
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
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
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
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 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 Commerce 1,010 packages
Distribution Nationwide Distribution to FL, GA, IL, IN, KY, MT, OH, PA, TX
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OCC and Original Applicant = ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
-
-