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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN 3000 Hematology Analyzer

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 Class 2 Device Recall CELLDYN 3000 Hematology Analyzersee related information
Date Initiated by FirmMay 11, 2007
Date PostedAugust 29, 2007
Recall Status1 Terminated 3 on June 19, 2008
Recall NumberZ-1198-2007
Recall Event ID 38322
510(K)NumberK890491 K955673 K980614 
Product Classification Hematology Analyzer - Product Code GKZ
ProductAbbott CELL-DYN 3000 Hematology Analyzer
Code Information Model number CELL-DYN 3000 CS: List Numbers 91323-01 and 91323-03, all serial numbers distributed on or before May 3, 2007. Model number CELL-DYN 3000 SL: List Numbers 91325-01 and 91325-03; all serial numbers distributed on or before May 3, 2007.
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		The product failed electrostatic discharge testing, which could result in product failure.
FDA Determined
Cause 2		Other
ActionMandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.
Quantity in Commerce3,429 units, all models
DistributionWorldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kong, Jamaica, Japan, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GKZ
510(K)s with Product Code = GKZ
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