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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 Device Recall CELLDYN Sapphire and CELLDYN 4000 see related information
Date Initiated by Firm April 17, 2006
Date Posted April 03, 2007
Recall Status1 Terminated 3 on November 28, 2007
Recall Number Z-0708-2007
Recall Event ID 37454
510(K)Number K961439  K051215  
Product Classification Diluent/Sheath Systems - 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 CA 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		 Other
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 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
510(K)s with Product Code = GIF and Original Applicant = ABBOTT LABORATORIES
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