FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Cytomics FC500 with CXP Software
- Recall number
- Z-0380-06
- Recalling firm
- Beckman Coulter Inc
- Product
- Cytomics FC500 with CXP Software
- Status
- Terminated
- Initiated
- 2005-11-23
- Posted
- 2006-01-11
- Terminated
- 2012-01-26
- Reason
- Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0
- Root cause
- Software change control
- Action
- A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided.
- Quantity
- 179
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Part Numbers 629636 629637
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JJF
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28