FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: DL 2000 Data Manager
- Recall number
- Z-1372-05
- Recalling firm
- Beckman Coulter Inc
- Product
- DL 2000 Data Manager
- Status
- Terminated
- Initiated
- 2005-06-20
- Posted
- 2005-08-16
- Terminated
- 2011-10-06
- Reason
- Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.
- Root cause
- Other
- Action
- Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem.
- Quantity
- 287
- Distribution
- Nationwide.
- Lot, serial or model codes
- Not Applicable but refers to software version 6.4.109f
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- 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