FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter
- Recall number
- Z-0571-03
- Recalling firm
- Beckman Coulter Inc
- Product
- Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter
- Status
- Terminated
- Initiated
- 2002-12-10
- Posted
- 2003-02-25
- Terminated
- 2004-04-21
- Reason
- Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.
- Root cause
- Other
- Action
- Firm will check and shorten sweepflow tubing on a next visit basis during routine service visits.
- Quantity
- 447
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- In the LH 700 series, all serial numbers up to AE1088. In the GENS series, all instruments.
- 510(k) numbers
- ["K962988","K011342"]
- PMA numbers
- not on file
- Product code
- not on file
- 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