FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: UniCel Dxl 800 Access Immunoassay System, P/N 973100.
- Recall number
- Z-0904-04
- Recalling firm
- Beckman Coulter Inc
- Product
- UniCel Dxl 800 Access Immunoassay System, P/N 973100.
- Status
- Terminated
- Initiated
- 2004-03-29
- Posted
- 2004-07-20
- Terminated
- 2004-09-07
- Reason
- Software coding error may cause a fatal error message.
- Root cause
- Other
- Action
- Each user will be contacted initially and then once more to ensure that the users have recieved the recall letter and have installed the new software included with the letter. Recall letters were sent March 29, 2003.
- Quantity
- 73
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- All software versions pior to version 1.4
- 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