Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1
FDA device recall Z-0197-2007 · posted 2006-11-21 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.
- Action taken
- Customer letter -- A Product Corrective Action (PCA) letter was sent the week of July 24, 2006 to all accounts that have FC500 with CXP Software 2.0 and 2.1 to inform them that a potential sample misidentification may occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlines actions to be taken to avoid mis-identification of patient results.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 416 (US) + 60 (Canada)
- Distribution
- Nationwide and Canada
- Date initiated
- 2006-07-26
- Date posted
- 2006-11-21
- Date terminated
- 2012-02-29
- 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 |