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U.S. Department of Health and Human Services

Class 2 Device Recall Celite ACT Cartridge

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  Class 2 Device Recall Celite ACT Cartridge see related information
Date Initiated by Firm December 03, 2010
Date Posted February 16, 2011
Recall Status1 Terminated 3 on July 16, 2013
Recall Number Z-1341-2011
Recall Event ID 57454
510(K)Number K992571  
Product Classification Activated whole blood clotting time - Product Code JBP
Product Celite ACT Cartridge

Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery organ transplantation and dialysis.
Code Information 510 K number K992571 serial numbers, lot numbers, expiration dates with amounts for each are listed below:  Serial Lot Expire Date Total R09241A 2/14/2010 6300 R09257 2/28/2010 11150 R09265 3/14/2010 1775 R09268B 3/14/2010 12475 R09274B 3/28/2010 10150 R09277 3/28/2010 13750 R09278B 3/28/2010 16975 R09284 3/28/2010 14375 R09285 3/28/2010 16725 R09291 4/14/2010 21825 R09292 4/14/2010 9600 R09297 4/14/2010 16800 R09298 4/14/2010 15100 R09298A 4/14/2010 12700 R09303C 4/28/2010 13925 R09304 4/28/2010 22400 R09306 4/28/2010 16825 R09307 4/28/2010 14025 R09317B 4/28/2010 10550 R09329C 5/14/2010 13225 R09330A 5/14/2010 16700 R09330B 5/14/2010 12675 R09340 5/28/2010 21750 S09344 5/28/2010 16325 S09353 6/14/2010 13925 S10015A 7/14/2010 7000 S10017 7/14/2010 8650 S10026A 7/14/2010 18900 S10027A 7/14/2010 16375 S10032A 7/28/2010 11925 S10041 7/28/2010 15725 S10042 7/28/2010 12850 S10047A 8/14/2010 11525 S10056D 8/14/2010 14175 S10061C 8/28/2010 18225 S10062 8/28/2010 5850 S10070 8/28/2010 11200 S10071 8/28/2010 12150 S10073 8/28/2010 13700 S10097 9/28/2010 22775 S10098 9/28/2010 12400 S10099 9/28/2010 16450 S10107B 10/14/2010 11950 S10113 10/14/2010 18575 S10114A 10/14/2010 10725 S10117A 10/14/2010 19400 S10118A 10/14/2010 16200 S10127A 10/28/2010 17050 S10127B 10/28/2010 18900 S10136A 10/28/2010 18250 S10150A 11/14/2010 18950 S10151 11/14/2010 20475 S10155 11/28/2010 6075 S10167B 11/28/2010 15150 S10171 12/14/2010 21650 S10171A 12/14/2010 18050 S10173C 12/14/2010 17200 S10186A 12/28/2010 5800 S10188 12/28/2010 17475 S10188A 12/28/2010 17450 S10192 12/28/2010 16850 S10193 12/28/2010 18625 S10193A 12/28/2010 17300 S10195 12/28/2010 1650 S10220C 1/28/2011 3450 S10241 2/14/2011 3050 S10247A 2/28/2011 6825 S10254C 2/28/2011 13475 S10258C 3/14/2011 2425 S10263B 3/14/2011 9250 S10263D 3/14/2011 2450 S10263E 3/14/2011 7450 S10264A 3/14/2011 7300 S10264C 3/14/2011 5625 S10278 3/28/2011 8025 S10278C 3/28/2011 6000 S10280B 3/28/2011 4975 S10288 3/28/2011 7325 S10288A 3/28/2011 7325 S10295 4/14/2011 7000 S10295A 4/14/2011 2800 S10299B 4/14/2011 8850 S10303C 4/28/2011 8425 S10308 4/28/2011 8975 S10308B 4/28/2011 9550 S10309 4/28/2011 10075 S10309C 4/28/2011 6425 S10309E 4/28/2011 12975 S10310A 4/28/2011 5200 S10310C 4/28/2011 275 T10224D 1/28/2011 21100 T10232A 2/14/2011 9200 T10259A 3/14/2011 13075 T10293A 4/14/2011 6625 T10294 4/14/2011 5825 T10294A 4/14/2011 7300 
Recalling Firm/
Manufacturer		 Abbott Point Of Care Inc.
400 College Rd E
Princeton NJ 08540-6607
For Additional Information Contact Peter J. Scott
609-454-9000
Manufacturer Reason
for Recall		 Celite ACT cartridges have increased numbers of values outside the accepted allowable error.
FDA Determined
Cause 2		 Device Design
Action On behalf of Abbott, Genco Pharmaceutical Services sent an "URGENT RECALL NOTICE" dated November 2010, on December 3, 2010 via Fedex to all consignees/customers. Abbott sent out notification packages to foreign consignees/customers on December 3, 2010. The notice described the product, problem and action to be taken by customers. The firm recommended that customers use cartridges within 12 hours of removal from refrigerated storage based on the instructions provided with the product. The customers were instructed to complete and return the Business Reply cards to acknowledge receipt of the communication and provide the letter to any customers that have recieved the product. If you have any additional questions, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care Representative. On February 27, 2012 Abbott sent an Important Product Information letter via Fed Ex to inform customers that i-Stat Celite ACT cartridges manufactured from the beginning of 2012 can now be stored for two weeks at room temperature as indicated on the cartridge box. Foreign consignees were notified on 2/28/2012. Users are instructed to complete business reply cards to acknowledge receipt of the communication and provide the letter to any customers that have received the product. Any additional questions can be answered by contacting 8003668020 option 1.
Quantity in Commerce 1164275 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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