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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 January 10, 2003
Date Posted February 05, 2003
Recall Status1 Terminated 3 on July 26, 2003
Recall Number Z-0541-03
Recall Event ID 25454
510(K)Number K011342  
Product Classification Counter, Differential Cell - Product Code GKZ
Product Coulter LH 700 Series Hematology Analyzers
Code Information All lots.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Lynne McBride
714-961-3626
Manufacturer Reason
for Recall		 Biohazard situation exists for users.
FDA Determined
Cause 2		 Other
Action Customers were sent letters instructing them to remove and replace affected pages in their manuals. Letters were sent January 10, 2003.
Quantity in Commerce 210
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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