Class 1 Device Recall INRatio 2 Monitors

• Date Initiated by Firm: December 05, 2014
• Date Posted: January 03, 2015
• Recall Status: Terminated on September 18, 2017
• Recall Number: Z-0882-2015
• Recall Event ID: 69964
• 510(K)Number: K072727 K110212 K092987
• Product Classification: Test, time, prothrombin - Product Code GJS
• Product: INRatio 2 Monitors; - 0200431 Alere INRatio 2 PT/INR Professional Testing System; - 0200432 Alere INRatio 2 PT/INR Home Monitoring System; - 0200433 Alere INRatio 2 PT/INR Home Monitoring System; - 0200457 Alere INRatio 2 Replacement Monitor; - 55112 Alere INRatio 2 Replacement Monitor; - 55131 Alere INRatio 2 Replacement Monitor; - 55128A Alere INRatio 2 PT/INR Professional Monitoring System; ; The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile.; ; Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.
• Code Information: All lots of part numbers 0200431, 0200432, 0200433, 0200457, 55112, 55131, and 55128A.
• 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: In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
• FDA Determined Cause: Under Investigation by firm
• Action: An Urgent: Medical Device Correction, dated December 5, 2014, was sent to Healthcare Professionals. The letter identified the affected product and reason for recall. Customers were instructed to: -Ensure they have read and understand the precautions described in the current product labeling (a complete list of product labeling is provided in Appendix A) and the additional precautions in this notice describing medical conditions that may increase the risk of obtaining a (falsely or erroneously) lower than expected INR result. The INRatio PT/INR Monitor system should NOT be used if the patient has any of the medical conditions described. -Verify that the patient has hematocrit within the range of 30% to 55%. If not, immediately transition the patient to an alternate INR monitoring method. -Perform INR verification testing for the patients using a laboratory INR test method. Immediately transition any patient with a significantly discrepant low result on the INRatio¿¿ PT/INR Monitor system to an alternative INR monitoring method. -If have forwarded product to another customer, please provide a copy of this letter to them. -Please complete and FAX or e-mail the enclosed Reply Form (Appendix B the last page of this notice) within 10 days to confirm your receipt of this notice. Customers can contact Alere INRatio Recall Hotline by phone at 1-877-929-2579, for questions regarding this notification. Additionally, a website has been established providing information and frequently asked questions. www.inr-care.com Please FAX or e-mail the completed Reply Form to: Alere San Diego, Inc. Fax: 1-877-929-2580 E-mail: Alere4319@stericycle.com.
• Quantity in Commerce: 231,967 Test Systems including Monitors
• Distribution: Worldwide Distribution -- US nationwide, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
• 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; 510(K)s with Product Code = GJS and Original Applicant = BIOSITE INCORPORATED; 510(K)s with Product Code = GJS and Original Applicant = HEMOSENSE, INC.