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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm September 08, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on March 30, 2004
Recall Number Z-0040-04
Recall Event ID 27251
Product Classification Counter, Differential Cell - Product Code GKZ
Product Coulter AcT 5diff Cap Pierce Hematology Analyzers

Part Numbers: 6605641, 6605705
Code Information None apply.
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Kathleen M. Jaker
Manufacturer Reason
for Recall
Samples with high fat content will not count platelets accurately.
FDA Determined
Cause 2
Action Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.
Quantity in Commerce 451
Distribution United States 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.