Recall Z-1069-2009 ยท GKZ Counter, Differential Cell
Abbott Laboratories
Hematology Reagent Syringe, List number 08H49-02, used on the CELL-DYN Sapphire Automated Hematology Analyzer, List Number 08H00-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA.
| Date | Apr 23, 2009 (initiated Dec 10, 2008) |
| Status | Terminated |
| Reason | Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 30 syringes |
| Distribution | Worldwide Distribution -- USA, Australia, Canada, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051215 | CELL-DYN SAPPHIRE SYSTEM Abbott Laboratories, Jul 21, 2005 |