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U.S. Department of Health and Human Services

Class 2 Device Recall CELLDYN 3500 Hematology Analyzer

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  Class 2 Device Recall CELLDYN 3500 Hematology Analyzer see related information
Date Initiated by Firm May 11, 2007
Date Posted August 29, 2007
Recall Status1 Terminated 3 on June 19, 2008
Recall Number Z-1199-2007
Recall Event ID 38322
510(K)Number K913305  K991605  K980614  K960427  K955715  
Product Classification Hematology Analyzer - Product Code GKZ
Product Abbott CELL-DYN 3500 Hematology Analyzer
Code Information Model number CELL-DYN 3500 CS, List Numbers 91340-01 and 91340-03, all serial numbers distributed before May 3, 2007. Model number CELL-DYN 3500 SL, List Numbers 91350-01 and 91350-03, all serial numbers distributed on or before May 3, 2007: 91350-01 1 EACH CD3500 SL ANALYZE(1 EACH) 1.000 0031192P, 91350-03 1 EACH CD3500SL ANAL-REF(1 EACH) 1.000 30336P96, 91350-03 1 EACH CD3500SL ANAL-REF 1.000 32159P96 05/05/2000, 91340-03 1 EACH CD 3300/3500CS(1 EACH) 1.000 30276N96 06/21/2000
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
Action Mandatory 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 Commerce 3,429 units, all models
Distribution Worldwide, 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 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
510(K)s with Product Code = GKZ and Original Applicant = SEQUOIA TURNER CORP.
510(K)s with Product Code = GKZ and Original Applicant = UNIPATH LTD.
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