Recall Z-0306-2009 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells.
| Date | Nov 21, 2008 (initiated Aug 25, 2008) |
| Status | Terminated |
| Reason | Exposed wire resulted in minor electrical shock and burn to the service technician |
| Root cause | Device Design |
| Action | Recall issued August 22, 2008. Technical service bulletin was issued for all field personnel via internal database. No customer communication is planned as customers are instructed *not* to remove the cover, which is necessary to access the area. |
| Quantity | 958 units |
| Distribution | Worldwide Distribution --- including USA and countries of Argentina, Australia, Brazil, Canada, Chile, China WFOTC, Colombia, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051215 | CELL-DYN SAPPHIRE SYSTEM Abbott Laboratories, Jul 21, 2005 |