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U.S. Department of Health and Human Services

Class 2 Device Recall CellDyn Ruby System

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  Class 2 Device Recall CellDyn Ruby System 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-2019-2011
Recall Event ID 58188
510(K)Number K061667  
Product Classification Differential Cell Counter - Product Code GKZ
Product CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer.

Abbott Diagnostics Division, Santa Clara, CA 05054
Code Information List Number 08H67-01; lot numbers: 35678BG, 35682BG to 35759BG, 35761BG to 35768BG, 35771BG, 34163BG, 34283BG, 34090BG, and 34862BG.
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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