FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: COULTER LH 700 Series Hematology Analyzers
- Recall number
- Z-0418-03
- Recalling firm
- Beckman Coulter Inc
- Product
- COULTER LH 700 Series Hematology Analyzers
- Status
- Terminated
- Initiated
- 2002-11-08
- Posted
- 2003-01-09
- Terminated
- 2003-07-17
- Reason
- Software.
- Root cause
- Other
- Action
- Customers received a telephone call and a faxed Product Corrective Action letter dated Nov. 8, 2002 which includes modified operating instructions. Additionally an updated software version was released and installed on all affected customers units. This recall is complete.
- Quantity
- 132
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Part number -6605632, No lot number applies, all serial numbers apply.
- 510(k) numbers
- not on file
- 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