Device Recall CELLDYN 4000 Automated Hematology Analyzer

List Number 07H95-01, manufactured between June 18 to November 11, 2009.

Hematology and Pathology Devices

2

No

Worldwide distribution: USA including states of: CA, CO, FL, GA, KY, NC, NJ, NY, OR, VA, and WV; and countries including: Argentina, Australia, Canada, Germany and Japan.

CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA || Medical device component. The CELL-DYN 4000 System is a multiparameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The vent head spring assembly is used in the auto-sampling mechanism on the CELL-DYN 4000.