Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter
FDA device recall Z-0571-03 · posted 2003-02-25 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.
- Action taken
- Firm will check and shorten sweepflow tubing on a next visit basis during routine service visits.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 447
- Distribution
- Nationwide and Canada
- Date initiated
- 2002-12-10
- Date posted
- 2003-02-25
- Date terminated
- 2004-04-21
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K011342) | Beckman Coulter, Inc. | 2001-07-09 |
| COULTER GEN-S SYSTEM (K962988) | Coulter Corp. | 1996-10-30 |