FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
- Recall number
- Z-1529-2008
- Recalling firm
- Beckman Coulter Inc
- Product
- Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
- Status
- Terminated
- Initiated
- 2007-08-20
- Posted
- 2008-08-08
- Terminated
- 2012-10-15
- Reason
- Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.
- Root cause
- Software design
- Action
- A Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is included. Questions and concerns regarding the notification should be directed to Beckman Coulter Customer Service at 1-800-526-7694.
- Quantity
- 141 units
- Distribution
- Worldwide Distribution --- including USA and country of Canada.
- Lot, serial or model codes
- All Software Versions
- 510(k) numbers
- ["K030828"]
- PMA numbers
- not on file
- Product code
- GKZ
- 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