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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/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Kathleen M. Jaker
714-961-3666
Manufacturer Reason
for Recall		 Samples with high fat content will not count platelets accurately.
FDA Determined
Cause 2		 Other
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.
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