LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645
FDA device recall Z-0669-03 · posted 2003-03-21 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Incorrect Hemoglobin result can be reported with software version 2A and higher.
- Action taken
- Customers were contacted by telephone and mail from 1/27/03 to 2/3/2003. Notice included modified operating instructions. A software fix is being developed and will be installed by Beckman personnel.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 234
- Distribution
- Nationwide and Canada.
- Date initiated
- 2002-12-27
- Date posted
- 2003-03-21
- 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 |