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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN Sheer Valve Assembly Driver

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  Class 2 Device Recall CELLDYN Sheer Valve Assembly Driver see related information
Date Initiated by Firm March 15, 2011
Date Posted April 29, 2011
Recall Status1 Terminated 3 on November 22, 2011
Recall Number Z-2020-2011
Recall Event ID 58188
510(K)Number K991605  
Product Classification Differential Cell Counter - Product Code GKZ
Product CELL-DYN Sheer Valve Assembly Driver

Abbott Diagnostics Division, Santa Clara, CA 05054
Code Information List Number 8921204902:  Date Code 20-Jan-2011 Pallet ID 48312339; Date Code 08-Feb-2011 Pallett ID 95795162.  List Number 8921167602: Date Code 13-Dec-2010 Pallet ID 80671954; Date Code 15-Dec-2010 Pallet ID 32777397; Date Code 16-Dec-2010 Pallet ID 46425128; Date Code 18-Jan-2011 Pallet ID 42387574; and Date Code 20-Jan-2011 Pallet ID 35758457.
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact Kelly E. Duffy
408-567-3560
Manufacturer Reason
for Recall		 The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
FDA Determined
Cause 2		 Pending
Action Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.
Quantity in Commerce 174 total units, all varieties
Distribution Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.
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 = GKZ and Original Applicant = ABBOTT LABORATORIES
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