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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 July 06, 2005
Date Posted August 17, 2005
Recall Status1 Terminated 3 on April 26, 2012
Recall Number Z-1377-05
Recall Event ID 32733
Product Classification Counter, Differential Cell - Product Code GKZ
Product Cytomics FC500 MPL with MXP Software versions 1.1 and 2.0
Code Information Versions 1.1 and 2.0
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nancy E. Johnson
714-961-4489
Manufacturer Reason
for Recall		 Software anomally. If the laser is shutdown or fluctuates outside of the specification limits, the software continues to run and will not indicate a laser failure, and could therefore cause erroneous results.
FDA Determined
Cause 2		 Other
Action Letters issued to users on July 13, 2005 which also included modified operating instructions, and response cards.
Quantity in Commerce 36
Distribution USA
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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