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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Point of Care Inc

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  Class 2 Device Recall Abbott Point of Care Inc see related information
Date Initiated by Firm June 15, 2015
Date Posted August 10, 2015
Recall Status1 Terminated 3 on February 19, 2016
Recall Number Z-2361-2015
Recall Event ID 71665
510(K)Number K020355  
Product Classification Test, time, prothrombin - Product Code GJS
Product i-Stat PT/INR Cartridges
List number 03P89-24
The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box.
a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
Code Information All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact
800-366-8020
Manufacturer Reason
for Recall		 Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.
FDA Determined
Cause 2		 Under Investigation by firm
Action Abbott Point of Care sent a recall letter dated June 15, 2015 via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the enclosed Business Reply Card (BRC). A Proof of Destruction From (FG-4533 in included with letter and is required to be returned to APOC as part of the credit process. Customers with questions were instructed to contact APOC Technical Support at 800-366-8020, Option 1 or their APOC representative.
Quantity in Commerce 423,168 cartridges
Distribution Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.
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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