Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Numb
FDA device recall Z-1069-2009 · posted 2009-04-23 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.
- Action taken
- Recall initiated on December 10, 2008. A product recall letter and reply form were cent to CELL-DYN Sapphire customers who received syringes between September 16, 2008 and October 28, 2008 to US customers, and to November 5, 2008 for Outside-of-US customers.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 30 syringes
- Distribution
- Worldwide Distribution -- USA, Australia, Canada, and Germany.
- Date initiated
- 2008-12-10
- Date posted
- 2009-04-23
- Date terminated
- 2010-12-27
- 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 SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |