Class 2 Device Recall Buprenorphine Test Strip

• Date Initiated by Firm: March 04, 2014
• Date Posted: April 07, 2014
• Recall Status: Terminated on May 09, 2014
• Recall Number: Z-1394-2014
• Recall Event ID: 67665
• Product: Buprenorphine Test Strip; LumiQuick,. Santa Clara, CA 95054
• Code Information: Catalog number: 74041 All lots
• Recalling Firm/ Manufacturer: LumiQuick Diagnostics Inc.; 2946 Scott Blvd; Santa Clara CA 95054-3312
• For Additional Information Contact: Doug Rundle; 408-855-0061
• Manufacturer Reason for Recall: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
• FDA Determined Cause: No Marketing Application
• Action: Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
• Quantity in Commerce: ALL
• Distribution: Distributed in the states of CA, FL, NJ, TX, and NY.

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.