Medical Device Software Defect May Cause Erroneous Lab Results
A software defect in VITROS 3600 Immunodiagnostic Systems (versions 3.8.0 and 3.8.1) prevents quality control rules from reporting failures as expected, potentially allowing invalid test results to be reported.
- Product
- VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
- Category
- Medical Device
- Distribution
- Distributed nationwide