Class 1 Device Recall Alere INRatio PT/INR Test Strips, Alere INRatio

• Date Initiated by Firm: December 05, 2014
• Date Posted: January 03, 2015
• Recall Status: Terminated on September 18, 2017
• Recall Number: Z-0880-2015
• Recall Event ID: 69964
• 510(K)Number: K020679 K021923 K072727 K092987 K110212
• Product Classification: Test, time, prothrombin - Product Code GJS
• Product: Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box. In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).
• Code Information: All lots of part numbers: 0100071 and 0100139.
• 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: 77,342 units (12 test strips/box) and 308,947 units (48 test strips/box)
• 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; 510(K)s with Product Code = GJS; 510(K)s with Product Code = GJS