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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN Sapphire and CELLDYN 4000

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 Class 2 Recall
CELLDYN Sapphire and CELLDYN 4000
see related information
Date Posted April 03, 2007
Recall Status1 Terminated on November 28, 2007
Recall Number Z-0708-2007
Recall Event ID 37454
Premarket Notification
510(K) Numbers
K051215  K961439 
Product Classification Diluent, Blood Cell - Product Code GIF
Product CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems- List No. 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Code Information All lots
Recalling Firm/
Manufacturer
Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara, California 95054-1113
Manufacturer Reason
for Recall
High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action On 4/17/06, the firm initiated the recall and its notification letters explained the reason for the recall and reported Abbott Field Service personnel will install and replace filters at all recall sites.
Quantity in Commerce 56,075 units
Distribution Worldwide Distribution-USA including states of AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV and Countriers of Argentina, Australia, Brazil, Hong Kong, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, and Venezuela.
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
510(K)s with Product Code = GIF and Original Applicant = ABBOTT LABORATORIES
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