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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT CREA Cartridge Blood Gas Panel

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  Class 2 Device Recall iSTAT CREA Cartridge Blood Gas Panel see related information
Date Initiated by Firm March 17, 2010
Date Posted November 24, 2010
Recall Status1 Terminated 3 on September 22, 2011
Recall Number Z-0456-2011
Recall Event ID 55178
510(K)Number K973292  
Product Classification Electrode, ion based, enzymatic, creatinine - Product Code CGL
Product i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, Inc., Princeton, NJ.
Code Information Lot numbers A09279A and A09280A, Exp March 2010
Recalling Firm/
Manufacturer		 Abbott Point of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Peter Scott
609-454-9270
Manufacturer Reason
for Recall		 The i-STAT CREA Cartridges may produce inaccurate (depressed) results at or near the end of the labeled expiry date when stored above 25 degrees for 2 weeks.
FDA Determined
Cause 2		 Other
Action Abbott Point of Care issued Urgent Product Recall Notification letters dated March 2010 to all direct customers identifying the affected product and the actions to be taken. Customers were instructed to determine if they had cartirdges that had been stored above 25 degrees Celsius, and if so, contact Abbott for replacement or credit. Abbott Technical Support can be contacted at 800-366-8020 option 1 about this recall.
Quantity in Commerce 34525 cartridges
Distribution Worldwide Distribution: Throughout USA and 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 = CGL and Original Applicant = I-STAT CORP.
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