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U.S. Department of Health and Human Services

Class 2 Device Recall iSTAT ACT Celite Cartridges

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  Class 2 Device Recall iSTAT ACT Celite Cartridges see related information
Date Initiated by Firm August 18, 2009
Date Posted February 23, 2010
Recall Status1 Terminated 3 on May 18, 2010
Recall Number Z-0813-2010
Recall Event ID 52754
510(K)Number K992571  
Product Classification Activated whole blood clotting time - Product Code JBP
Product Abbott i-STAT ACT Celite Cartridges.

In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples.
Code Information Catalog number: 07G01-1
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		 Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Abbott Point of Care issued an "Important Product Information" letter beginning August 18, 2009. Consignees were instructed on how to reconcile all affected product. For further information, contact Abbott Point of Care Technical Support at 1-800-366-8020, Option 1.
Quantity in Commerce 696,675 Cartridges
Distribution Worldwide distribution.
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 = JBP and Original Applicant = I-STAT CORP.
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