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Class 2 Device Recall CELLDYN Sapphire and CELLDYN 4000 |
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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
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Product Classification |
Diluent/Sheath Systems - Product Code GIF
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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
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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.
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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
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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.
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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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