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U.S. Department of Health and Human Services

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

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  Class 1 Device Recall Alere INRatio PT/INR Test Strips, Alere INRatio see related information
Date Initiated by Firm December 05, 2014
Date Posted January 03, 2015
Recall Status1 Terminated 3 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 2		 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 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.
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