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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN 4000 Automated Hematology Analyzer

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  Class 2 Device Recall CELLDYN 4000 Automated Hematology Analyzer see related information
Date Initiated by Firm December 29, 2009
Date Posted March 11, 2011
Recall Status1 Terminated 3 on March 11, 2011
Recall Number Z-1623-2011
Recall Event ID 54468
510(K)Number K961439  
Product Classification Counter, differential cell - Product Code GKZ
Product CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA

Medical device component. The CELL-DYN 4000 System is a multiparameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The vent head spring assembly is used in the auto-sampling mechanism on the CELL-DYN 4000.
Code Information List Number 07H95-01, manufactured between June 18 to November 11, 2009.
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact Kelly Duffy
408-982-4800
Manufacturer Reason
for Recall		 A component used in assembly is out of specification, resulting in failure to retract, eject specimens, exposure below the safety zone, piercing of specimen tubes, or error message to display.
FDA Determined
Cause 2		 Other
Action The firm, Abbott Laboratories, sent an "Urgent Field Safety Notice Product Recall" letter dated December 28, 2009 to the Customers via Federal Express. The letter described the product, problem and action to be taken. The customers were instructed to destroy any CELL-DYN 4000 Vent Head Spring Assemblies that they have on hand and have not installed; (No action is necessary for assemblies that are currently installed on the CELL-DYN 4000 Analyzer); complete and return the Customer Reply form (even if they do not have the product) via fax to 1-800-777-0051 or email: QAGCO@abbott.comProduce Recall; indicate the number of Vent Head Spring Assemblies destroyed. the number identified will be replaced with Vent Head Spring Assemblies that meet specifications, and to please keep this communication with their CELL-DYN 4000 System Operator's Manual. If you have any questions regarding this communication, U.S. customers should call Customer Support at 1-877-4ABBOTT (1-877-422-2688). Customers outside the U.S., please contact your local hematology customer support representative.
Quantity in Commerce 157 assemblies
Distribution Worldwide distribution: USA including states of: CA, CO, FL, GA, KY, NC, NJ, NY, OR, VA, and WV; and countries including: Argentina, Australia, Canada, Germany and Japan.
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 DIAGNOSTICS
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