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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN 3200

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  Class 2 Device Recall CELLDYN 3200 see related information
Date Initiated by Firm September 29, 2004
Date Posted April 03, 2007
Recall Status1 Terminated 3 on May 01, 2007
Recall Number Z-0706-2007
Recall Event ID 37453
510(K)Number K972354  
Product Classification Reagent - Product Code GIF
Product CELL-DYN 3200 Diluent/Sheath Reagent,
List Number 03H79-01,Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Code Information Lot Numbers: 14465I2,  15597I2,  15598I2,  16752I2,  16753I2,  16754I2,  17943I2,  17946I2,  17947I2,  17949I2,  17950I2,  17952I2,  17953I2,  17954I2,  18107I2,  18108I2,  18109I2,  18110I2
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
Manufacturer Reason
for Recall		 Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range
FDA Determined
Cause 2		 Other
Action On September 29, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.
Quantity in Commerce 27,411 units
Distribution Class II Recall-Worldwide Distribution- USA including states of IL, TX, GA, and PA. and countries of Argentina, Australia, Bahamas, Barbados, Brazil, British Virgin Islands, Colombia, Dominican Republic, Germany, Hong Kong, Japan, Korea, New Zealand, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad & Tobago, Uruguay, and Venezuela.
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 = GIF and Original Applicant = ABBOTT LABORATORIES
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