Immunoassay Analyzer Software Error May Cause Sample Result Mix-up
The DxI 9000 Access Immunoassay Analyzer may mix up test results from different patient samples. A software defect causes the system to replace current sample barcodes with previously-used IDs, potentially associating wrong results with wrong patients.
- Product
- DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
- Category
- Medical Device
- Distribution
- Distributed nationwide