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U.S. Department of Health and Human Services

Class 3 Device Recall LH 700

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  Class 3 Device Recall LH 700 see related information
Date Initiated by Firm December 27, 2002
Date Posted March 21, 2003
Recall Status1 Terminated 3 on July 26, 2003
Recall Number Z-0669-03
Recall Event ID 25630
510(K)Number K011342  
Product Classification Counter, Differential Cell - Product Code GKZ
Product LH 700 Series Hematology Analyzers.

Part numbers 66056032, 6605633, 6605645
Code Information All instruments with version 2A or higher.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
Manufacturer Reason
for Recall		 Incorrect Hemoglobin result can be reported with software version 2A and higher.
FDA Determined
Cause 2		 Other
Action Customers were contacted by telephone and mail from 1/27/03 to 2/3/2003. Notice included modified operating instructions. A software fix is being developed and will be installed by Beckman personnel.
Quantity in Commerce 234
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.
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