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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN 4000

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  Class 2 Device Recall CELLDYN 4000 see related information
Date Initiated by Firm May 12, 2004
Date Posted March 16, 2007
Recall Status1 Terminated 3 on May 01, 2007
Recall Number Z-0639-2007
Recall Event ID 37450
510(K)Number K961439  
Product Classification Reagent - Product Code GIF
Product CELL-DYN 4000 Diluent/Sheath Reagent,
List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Code Information Lot Numbers:  14454I2, 14455I2,  14456I2,  14457I2,  15611I2
Recalling Firm/
Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
Manufacturer Reason
for Recall
Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
FDA Determined
Cause 2
Action On May 12, 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 6,893 units
Distribution Class II- Worldwide Distribution-USA including the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, WA, WI, and WV and countries of Argentina, Brazil, Hong Kong, Japan, Malaysia, Singapore, Taiwan, and Thailand.
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 DIAGNOSTICS