Class 1 Device Recall INRatio2 PT/INR Home Monitoring System

• Date Initiated by Firm: July 11, 2016
• Date Posted: August 19, 2016
• Recall Status: Terminated on July 20, 2017
• Recall Number: Z-2358-2016
• Recall Event ID: 74665
• 510(K)Number: K110212
• Product Classification: Test, time, prothrombin - Product Code GJS
• Product: Alere INRatio2 PT/INR Home Monitoring System; Model Number: 0200432, 0200433; ; Product Usage:; Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio¿2 PT/INR Home Monitoring System is not intended to be used for screening purposes.
• Code Information: All Lots All Serial Numbers
• Recalling Firm/ Manufacturer: Alere San Diego, Inc.; 9975 Summers Ridge Rd; San Diego CA 92121-2997
• For Additional Information Contact: Jackie Lustig; 781-341-4009
• Manufacturer Reason for Recall: Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System (Test Strips and Meters). This action is being initiated as a result of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio¿/INRatio¿2 PT/INR Monitoring System but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
• FDA Determined Cause: Other
• Action: Alere issued a press release on July 11, 2016. An Urgent Medical Device Letter dated July 26, 2016 was sent to affected customers on July 29, 2016. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to consult with their healthcare provider as soon as possible to transition to an alternate method of PT/INR testing and to contact the firm regarding return or disposal of unused product and obtaining device replacement from a different manufacturer. For questions contact the Alere INRatid1 Recall Hotline at 1-866-723-2535.
• Distribution: Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.
• 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 = GJS and Original Applicant = ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE