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U.S. Department of Health and Human Services

Class 2 Device Recall Cytomics FC500 MPL with MXP Software

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  Class 2 Device Recall Cytomics FC500 MPL with MXP Software see related information
Date Initiated by Firm October 17, 2006
Date Posted December 27, 2006
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0317-2007
Recall Event ID 36822
Product Classification Counter, Differential Cell - Product Code GKZ
Product FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit
Code Information System with MXP Software Version 2.0 & 2.1
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall		 The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.
FDA Determined
Cause 2		 Other
Action A Product Corrective Action (PCA) letter was mailed on Oct 17, 2006 to FC500 MPL and MXP software accounts. They are informed that if the operator opens the Parameter Selection Dialogue box after parameters have been selected for the RATIO Parameter, the selected parameters could revert back to the default choices. If these same parameters were used in the creation of the RATIO Parameter in any other saved protocol, the protocols will also be changed once they are opened after the error occurs. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter. Consignees are asked to complete and return the enclosed Response Form within 10 days.
Quantity in Commerce 37 units in the US; 4 units in Canada
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.
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