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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT PT/INR Cartridge

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  Class 2 Device Recall iSTAT PT/INR Cartridge see related information
Date Initiated by Firm May 05, 2010
Date Posted July 13, 2010
Recall Status1 Terminated 3 on September 22, 2011
Recall Number Z-1996-2010
Recall Event ID 55895
510(K)Number K020355  
Product Classification Test, time, prothrombin - Product Code GJS
Product i-STAT PT/INR Cartridge
Abbott Point of Care, Princeton, NJ
Code Information Catalog numbers: 04J50-01, 04J50-02. Lot numbers: N09315, exp 4/28/2010; N09323, exp 5/14/2010; N09323A, exp 5/14/2010; N09346A, exp 5/28/2010; S09347, exp 5/28/2010; S09354, exp 6/14/2010; T10009, exp 6/28/2010; T10011, exp 6/28/2010.
Recalling Firm/
Abbott Point of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Mr. Peter J. Scott
Manufacturer Reason
for Recall
A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagluation therapy may be given and issues with clotting and/or thrombosis could occur. No reports of injury have been received.
FDA Determined
Cause 2
Action Urgent recall notifications were sent on May 13 2010. Customers were instructed to discontinue use and to return the identified lots. Additional questions are directed to Abbott Point of Care Technical Support at 800-366¿8020, Option 1 or your Abbott Point of Care representative.
Quantity in Commerce 44976 in US, 3648 in rest of world.
Distribution Worldwide distribution: Argentina, Hong Kong, China, Finland, Greece, India, Portugal, Russian Federation, Saudi Arabia, United Arab Emirates, Italy, Spain, Australia, Germany, UK, Sweden, The Netherlands, France, Canada.
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 = I-STAT CORPORATION