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U.S. Department of Health and Human Services

Class 3 Device Recall COULTER GEN.S Series Hematology Analyzer

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  Class 3 Device Recall COULTER GEN.S Series Hematology Analyzer see related information
Date Initiated by Firm December 15, 2005
Date Posted February 04, 2006
Recall Status1 Terminated 3 on January 26, 2012
Recall Number Z-0475-06
Recall Event ID 34380
510(K)Number K962988  
Product Classification Spinner, Slide, Automated - Product Code GKJ
Product COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R
Code Information PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R All Software Versions 
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall		 There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
FDA Determined
Cause 2		 Other
Action A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail)
Quantity in Commerce 1134
Distribution Nationwide and Canada
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 = GKJ and Original Applicant = COULTER CORP.
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