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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN 1700CS

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  Class 2 Device Recall CELLDYN 1700CS see related information
Date Initiated by Firm June 08, 2009
Date Posted May 20, 2010
Recall Status1 Terminated 3 on December 03, 2010
Recall Number Z-1629-2010
Recall Event ID 53212
510(K)Number K870233  
Product Classification multiparameter hematology analyzer - Product Code gkz
Product CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA
Code Information Control Number 42285V 42283V 42261V 42262V 42279V 42184V96 40655V96 42268V 42284V 42267V 40437V96 
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information Contact
408-982-4800
Manufacturer Reason
for Recall		 Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A Product Correction Letter and Customer Rely Form were sent to all currently active Cell -Dyn Sapphire customer. New customers are being notified with a Product Information Letter. For questions regarding this information, U,S, customers should call Customer Support at 1-877-4ABBOTT. Customers outside the U.S., please contact your local hematology customer support representative.
Quantity in Commerce 11 units
Distribution Worldwide distribution: United States, Canada, Mexico, Anguilla, Australia, Argentina, Belize, Bermuda, Brazil, China, Chile, Columbia, Costa Rica, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Japan, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Uruguay, and Venezuela.
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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