Recall Z-1064-2009 ยท GKZ Counter, Differential Cell
Abbott Laboratories
CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes.
| Date | Apr 10, 2009 (initiated Nov 17, 2008) |
| Status | Terminated |
| Reason | Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count. |
| Root cause | Other |
| Action | Recall initiated on 11/17/2008. A Product Correction letter and customer reply form is sent to all currently active CELL-DYN Ruby customers. The customers are asked to keep the communication with their CELL-DYN Ruby System Operator's Manual and to note that the information listed in the table replaces the carryover specification provided in all applications of the manual. Questions from customers in the US should be directed to Customer Support at 1-877-4ABBOTT. Customers outside the US should contact their local hematology customer support representative. |
| Quantity | 899 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061667 | CELL-DYN RUBY SYSTEM Abbott Laboratories, Jul 10, 2006 |