FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
- Recall number
- Z-0583-06
- Recalling firm
- Beckman Coulter Inc
- Product
- UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
- Status
- Terminated
- Initiated
- 2006-02-06
- Posted
- 2006-03-03
- Terminated
- 2012-03-06
- Reason
- The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)
- Root cause
- Software design
- Action
- A Product Corrective Action letter will be mailed the week of Feb 06 2006 to all UniCel 800 Dxl customers informing them of a rare condition on the UniCel Dxl 800 Access Immunoassay Systems. Under a specific set of circumstances, the UniCel Dxl 800 may aspirate a sample from an incorrect rack and generate a result, which is not flagged. (Letter is sent by US mail)
- Quantity
- 280 total (263 in US & 17 in Canada)
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Part Numbers: 386162 (software) 973100 (Instrument), Software Versions 2.2.1 and earlier.
- 510(k) numbers
- ["K023764"]
- PMA numbers
- not on file
- Product code
- JJE
- 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