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U.S. Department of Health and Human Services

Class 2 Device Recall ISTAT PT/INR cartridges

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  Class 2 Device Recall ISTAT PT/INR cartridges see related information
Date Initiated by Firm March 01, 2012
Date Posted August 08, 2012
Recall Status1 Terminated 3 on February 08, 2013
Recall Number Z-2157-2012
Recall Event ID 62536
510(K)Number K020355  
Product Classification Test, time, prothrombin - Product Code GJS
Product I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA

This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
Code Information List number 04J50-01 04J5O-02 03P89-24  Lots begininng with R11 or R12
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Mr. Larry Krasley
609-454-9292
Manufacturer Reason
for Recall		 The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
FDA Determined
Cause 2		 Process control
Action Abbott Point of Care Inc, sent a URGENT RECALL NOTICE dated March 2012 , to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were provided in the letter with instructions in the letter on how to handle the affected product. Please complete and return the enclosed Business Reply card to acknowledge receipt of this communication and installation of the interium software CLEW and also 1) Update all handhelds 2) download appropriate assignment sheets. For further questions please call (609) 454-9000.
Quantity in Commerce 2,950,296 cartridges US; 156,408 cartridges OUS
Distribution Worldwide Distribution -- (USA) nationwide
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
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