FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Synchron LX Systems Version 4.5 Operating Software
- Recall number
- Z-0009-06
- Recalling firm
- Beckman Coulter Inc
- Product
- Synchron LX Systems Version 4.5 Operating Software
- Status
- Terminated
- Initiated
- 2005-09-06
- Posted
- 2005-10-06
- Terminated
- 2012-01-26
- Reason
- Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.
- Root cause
- Software design
- Action
- Customers were notified by letter dated September 6, 2005 with work around instruction provided in the letter.
- Quantity
- 868
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Synchron LX 20 and PRO Version 4.5 Operating Software Part Number A21127 (Upgrade Kit) Software Versions V4.5N4.6 CDB (Chemistry Database). Synchron LXi Version 4.5 Operating Software A21128 (Upgrade Kit) Software Versions V4.5N4.6 CDB(Chemistry Database).
- 510(k) numbers
- ["K011213","K023049","K965240"]
- 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