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.
Recall
- Recall Number
- Z-1064-2009
- Event Number
- 50478
- Firm
- Abbott Laboratories
- FEI Number
- 2919069
- Product Code
- GKZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 17, 2008
- Posted
- April 10, 2009
- Terminated
- November 27, 2010
- Address
- 5440 Patrick Henry Dr, Santa Clara, CA, 95054-1113
Description
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.
Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.
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.
Worldwide Distribution
899 units