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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJuly 06, 2005
Date PostedAugust 17, 2005
Recall Status1 Terminated 3 on April 26, 2012
Recall NumberZ-1377-05
Recall Event ID 32733
Product Classification Counter, Differential Cell - Product Code GKZ
ProductCytomics FC500 MPL with MXP Software versions 1.1 and 2.0
Code Information Versions 1.1 and 2.0
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactNancy 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
ActionLetters issued to users on July 13, 2005 which also included modified operating instructions, and response cards.
Quantity in Commerce36
DistributionUSA
Total Product Life CycleTPLC 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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