Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604
FDA device recall Z-0039-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Samples with high fat content will not count platelets accurately.
- Action taken
- Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 36
- Distribution
- United States and Canada
- Date initiated
- 2003-09-08
- Date posted
- 2003-10-15
- Date terminated
- 2004-03-30
- 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 |
|---|---|---|
| ABX PENTRA 60 HEMATOLOGY ANALYZER (K992511) | Abx Diagnostics | 1999-10-15 |