Coulter LH 700 Series Hematology Analyzers
FDA device recall Z-0541-03 · posted 2003-02-05 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Biohazard situation exists for users.
- Action taken
- Customers were sent letters instructing them to remove and replace affected pages in their manuals. Letters were sent January 10, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 210
- Distribution
- Nationwide and Canada.
- Date initiated
- 2003-01-10
- Date posted
- 2003-02-05
- Date terminated
- 2003-07-26
- 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 |