Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01
FDA device recall Z-0648-03 · posted 2003-03-13 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Product elicits fluorescent signal interference due to contamination.
- Action taken
- On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 1383 units
- Distribution
- Nationwide and Argentina, Canada and Puerto Rico.
- Date initiated
- 2002-10-16
- Date posted
- 2003-03-13
- Date terminated
- 2003-08-21
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY (K010953) | Abbott Laboratories | 2001-06-06 |
| ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY (K981342) | Abbott Laboratories | 1998-06-29 |
| ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) (K971152) | Abbott Laboratories | 1997-08-12 |
| ABBOTT CELL-DYN 4000 SYSTEM (K961439) | Abbott Diagnostics | 1996-10-18 |