Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2
FDA device recall Z-0455-2009 · posted 2009-01-07 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Software error: The recall was initiated after Beckman Coulter identified that the CXP User documentation does not adequately characterize the use of the Live Gate feature. The primary use of a Live Gate is for the international removal of unwanted events, such as debris. The data outside of the Live Gate will not be stored to the final listmode file, this reducing the data set size. The softwa
- Action taken
- The customer notifications were initiated by Beckman Coulter on July 23, 2007 when a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers that the user documentation does not adequately characterize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate and actions to be taken. For further information, please contact Beckman Coulter, Inc. by telephone at 714-993-5321.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 565
- Distribution
- Globally to the United States and Canada.
- Date initiated
- 2007-08-01
- Date posted
- 2009-01-07
- Date terminated
- 2009-01-13
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) (K030828) | Beckman Coulter, Inc. | 2003-05-21 |