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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN 4000

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 Class 2 Recall
CELLDYN 4000
see related information
Date Posted March 16, 2007
Recall Status1 Terminated on May 01, 2007
Recall Number Z-0639-2007
Recall Event ID 37450
Premarket Notification
510(K) Number
K961439 
Product Classification Diluent, Blood Cell - 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/
Manufacturer
Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara, California 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GIF and Original Applicant = ABBOTT DIAGNOSTICS
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