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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott iSTAT PT/INR cartridges

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 Class 2 Recall
Abbott iSTAT PT/INR cartridges
see related information
Date Posted December 04, 2013
Recall Status1 Terminated on May 29, 2014
Recall Number Z-0451-2014
Recall Event ID 66757
Premarket Notification
510(K) Number
K020355 
Product Classification Test, Time, Prothrombin - Product Code GJS
Product Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
Code Information K020355 List number 04J50-01, 04J50-02; 03P89-24 Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A
Recalling Firm/
Manufacturer
Abbott Point Of Care Inc.
400 College Rd E
Princeton, New Jersey 08540-6607
For Additional Information Contact Abbott Point of Care Technical Support
800-366-8020
Manufacturer Reason
for Recall
Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Abbott Point of Care Inc. (APOC) issued an Urgent Recall Notice on October 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of cartridges from PT/INR lots in this letter. All unused cartridges would be credited and are to be returned as instructed on the enclosed Business Reply Card. If customers provided cartridges from the lot number listed above to another institution they were instructed to provide a copy of this letter to them. Customers with questions were instructerd to contact Abbott Point of Care Technical at 1-800-366-8020, Option 1. For questions regarding this recall call 800-366-8020.
Quantity in Commerce 794,928 units US; 119,472 units OUS
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GJS and Original Applicant = I-STAT CORPORATION
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