Date Initiated by Firm | October 11, 2007 |
Date Posted | January 13, 2009 |
Recall Status1 |
Terminated 3 on January 13, 2009 |
Recall Number | Z-0129-2009 |
Recall Event ID |
48188 |
510(K)Number | K030828 |
Product Classification |
Automated Differential Cell Counter - Product Code GKZ
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Product | Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file. |
Code Information |
Part Number: 626553; Software version 2.2 |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
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For Additional Information Contact | 714-993-5321 Ext. 8383 |
Manufacturer Reason for Recall | Software error: This field action was initiated after Beckman Coulter determined that the CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user should refresh the dataset after changes are made. |
FDA Determined Cause 2 | Software design |
Action | Software error: A Product corrective Action (PCA) letter was mailed via US Postal Service on October 17, 2007 to all Cytomics FC 500 Flow Cytometry System with CXP Software accounts. This letter was entitled "URGENT: PRODUCT CORRECTIVE ACTION." Customers were informed that the user documentation does not clearly state that the user should refresh the dataset after changes are made. The letters provide the customers with an explanation and action to be taken whenever a protocol containing data is modified by making changes to cytosettings, regions or gates.
Customer were instructed to review all data plots and results before reporting results out. any uncharacteristic patterns in the data or unexpected results must be verified by running Quality Control and if necessary, preparing new samples.
In addition, customer were instructed to please share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Also they were asked to complete and return the an attached Customer Response Form within ten days.
Customers with questions or concerns regarding the notification, could call Beckman Coulter Customer Service at 1-800-526-7694 in the United States or Canada. Outside the US and Canada, they were to contact their local Beckman Coulter Representative. |
Quantity in Commerce | 594 Worldwide: 518 in the United States and 76 in Canada |
Distribution | Globally - United States and Canada |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = GKZ
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