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Class 2 Device Recall CELLDYN Sheer Valve Assembly Driver |
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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
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Product Classification |
Differential Cell Counter - Product Code GKZ
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Product |
CELL-DYN Sheer Valve Assembly Driver
Abbott Diagnostics Division, Santa Clara, CA 05054
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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
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For Additional Information Contact |
Kelly E. Duffy 408-567-3560
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Manufacturer Reason for Recall |
The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
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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
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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 = GKZ and Original Applicant = ABBOTT LABORATORIES
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