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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN

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  Class 2 Device Recall CELLDYN see related information
Date Initiated by Firm November 30, 2009
Date Posted March 17, 2011
Recall Status1 Terminated 3 on March 18, 2011
Recall Number Z-1698-2011
Recall Event ID 54665
510(K)Number K991142  K870233  K030513  K980614  K972354  K951496  
Product Classification Counter, differential cell - Product Code GKZ
Product The Waste Line Assembly and the Waste Outlet Tubing and the Waste Bottle Cable are components that are used on one or more CELL-DYN Systems.

Usage: Accessories to human waste container systems
Code Information Model Numbers: 92161-02 and 06H54-01 for the Waste Line Assembly; 02H96-01 for the Waste Outlet Tubing; and 03H98-02 for the Waste Bottle Cable.
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact Kelly E. Duffy
408-567-3698
Manufacturer Reason
for Recall		 The use of the device assemblies has been extended to a 6 month useful life.
FDA Determined
Cause 2		 Other
Action The firm, Abbott Laboratories, sent a "Product Correction" letter dated November 30, 2009 to all consignees/customers. The letter described the product, problem and actions to be taken. The letter stated that Abbott recommended that the customers change their Waste Line Assembly and Waste Outlet Tubing every six months and included a tag in the letter to record installation and replacement dates. Additionally, the customers were instructed to keep this communication with their CELL-DYN System Operator's Manual and complete and return the Customer Reply form via fax to 1-800-777-0051 or email QAGCO@abbott.com even if they no longer have the instrument. If you have any questions regarding this communication, U.S. customers should call Customer Support at 1-877-4ABBOTT (1-877-422-2688). Customers outside the U.S. please contact your local hematology customer support representative.
Quantity in Commerce 874
Distribution Worldwide distribution: AL, AR, AZ, CA. CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, MT , NC, NE, NJ, NM, NY, OH, OK, PA, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and countries including: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Panama, Peru, Puerto Rico, Singapore, South Korea, Thailand, Trinidad and Tobago, and Uruguay.
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 = GKZ and Original Applicant = ABBOTT DIAGNOSTICS
510(K)s with Product Code = GKZ and Original Applicant = ABBOTT LABORATORIES
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