Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
Recall
- Recall Number
- Z-1529-2008
- Event Number
- 46370
- Firm
- Beckman Coulter Inc
- FEI Number
- 2050012
- Product Code
- GKZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- August 20, 2007
- Posted
- August 8, 2008
- Terminated
- October 15, 2012
- Address
- 200 S Kraemer Blvd, Brea, CA, 92822-6208
Description
Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.
A Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is included. Questions and concerns regarding the notification should be directed to Beckman Coulter Customer Service at 1-800-526-7694.
Worldwide Distribution --- including USA and country of Canada.
141 units