Class 2 Device Recall BinaxNOW

• Date Initiated by Firm: March 28, 2007
• Date Posted: May 23, 2007
• Recall Status: Terminated on September 08, 2008
• Recall Number: Z-0823-2007
• Recall Event ID: 37843
• 510(K)Number: K062109
• Product Classification: Influenza A&B Test Kit - Product Code GNX
• Product: BinaxNOW Influenza A&B 22 Test Kit; Part Number: 416-022, contains NP Swabs with '8995' labeled on the swab wrapper
• Code Information: Kit Lot Numbers:024020, 024175, 024360, 024361, 024385, 024596, 024597, 024703, 024705, 024704, 024714, 024715, 024718, 024726, 025087 NP Swabs Lot Number: 8995
• Recalling Firm/ Manufacturer: Binax, Inc. dba IMPD; 10 Southgate Rd; Scarborough ME 04074-8303
• For Additional Information Contact: Jenny Fuchs; 207-730-5700
• Manufacturer Reason for Recall: Tip of the foam swab could detach from the shaft causing injury to the patient.
• FDA Determined Cause: Other
• Action: Inverness Medical issued recall notification by letter on 3/28/07. Customers are instructed to discard the NP swabs provided in the kits. The firm will replace the NP swabs. In the meantime customers are to use the tests with nasal wash/aspirate samples (influenza) or nasal wash samples (RSV). Response letters are to be signed by customers and returned to Inverness Medical.
• Quantity in Commerce: 3480 kits
• Distribution: Nationwide and Japan.
• 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 = GNX and Original Applicant = BINAX, INC.