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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 08, 2002
Date Posted January 09, 2003
Recall Status1 Terminated 3 on July 17, 2003
Recall Number Z-0415-03
Recall Event ID 25104
510(K)Number K011342  K022161  
Product Classification Counter, Differential Cell - Product Code GKZ
Product COULTER LH 700 Series Hematology Analyzers
Code Information Part number -6605632, No lot number applies, all serial numbers apply.
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Lynne McBride
Manufacturer Reason
for Recall
Software vote out logic changed. Erroneous white blood cell counts.
FDA Determined
Cause 2
Action Customers received a telephone call and a faxed Product Corrective Action letter dated Nov. 8, 2002 which includes modified operating instructions. Additionally an updated software version was released and installed on all affected customers units. This recall is complete.
Quantity in Commerce 132
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 = GKZ and Original Applicant = BECKMAN COULTER, INC.