CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP An
FDA device recall Z-0420-2007 · posted 2007-02-08 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Two workflow scenarios associated with renaming regions may produce incorrect results.
- Action taken
- A Product Corrective Action (PCA) letter was sent on the week of August 29, 2006 to all accounts that have an FC500 or have ordered CXP or MXP software to inform them that a) incorrect statistics are generated when a polygonal region with vertical re-entrant vertices is renamed using the Region Properties dialog box. b)when a region is copied from one plot to another, and then the new region is renamed, the statistics are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate user preventive action to remedy both issues. A response form is included for consignees to return to recalling firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 200 units nationwide
- Distribution
- Nationwide & Canada
- Date initiated
- 2006-08-29
- Date posted
- 2007-02-08
- Date terminated
- 2012-04-19
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) (K030828) | Beckman Coulter, Inc. | 2003-05-21 |