FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265
- Recall number
- Z-0637-04
- Recalling firm
- Beckman Coulter Inc
- Product
- Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265
- Status
- Terminated
- Initiated
- 2004-02-13
- Posted
- 2004-07-20
- Terminated
- 2012-05-08
- Reason
- Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.
- Root cause
- Other
- Action
- Firm sent modified operating instructions to users on 13 February 2004.
- Quantity
- 390
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Version 1.0
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKL
- 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