CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
FDA device recall Z-0527-06 · posted 2006-02-16 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.
- Action taken
- The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 871 units
- Distribution
- Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.
- Date initiated
- 2005-12-16
- Date posted
- 2006-02-16
- Date terminated
- 2006-04-13
- 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 |