Class 2 Device Recall iSTAT ACT Kaolin Cartridges

• Date Initiated by Firm: October 06, 2010
• Date Posted: November 17, 2010
• Recall Status: Terminated on August 22, 2012
• Recall Number: Z-0400-2011
• Recall Event ID: 57005
• 510(K)Number: K023582
• Product Classification: Activated whole blood clotting time - Product Code JBP
• Product: i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
• Code Information: List numbers: 07G81-01, 07G81-02; Lot numbers: S10129, S10129A, S10130, S10130B, S10147A, S10147B, S10147C, S10147D, S10147E, S10148A, S10148B, S10148C, S10148D, S10148G, S10149, S10149B, S10149C, S10151A, S10151B, S10152, S10152A, S10152B, S10152C, S10152D, S10152E, S10152F, S10154A, S10154B, S10154D, S10160B, S10162.
• Recalling Firm/ Manufacturer: Abbott Point Of Care Inc.; 400 College Rd E; Princeton NJ 08540-6607
• For Additional Information Contact: Peter J Scott; 609-454-9270
• Manufacturer Reason for Recall: Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
• FDA Determined Cause: Other
• Action: Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US 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 the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material. Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material. All unused cartridges will be credited and will be returned. If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.
• Quantity in Commerce: 95,325 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