FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Coulter LH750 Hematology Analyzer. Part Number 6605632.
- Recall number
- Z-0905-04
- Recalling firm
- Beckman Coulter Inc
- Product
- Coulter LH750 Hematology Analyzer. Part Number 6605632.
- Status
- Terminated
- Initiated
- 2004-03-31
- Posted
- 2004-07-20
- Terminated
- 2012-04-30
- Reason
- If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation.
- Root cause
- Other
- Action
- A Product Corrective Action Letter was mailed to all customers who currently have the instrument in thier lab. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occuring. The letter was sent by US Mail on March 31, 2004.
- Quantity
- 981
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Software versions 2A2 and 2B1.
- 510(k) numbers
- ["K011342"]
- 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