Laboratory Sample Preparation System Software and Instructions with Processing Defects
Beckman Coulter's CellMek SPS Sample Preparation System has incorrect dead volume specifications in its instructions and a software defect affecting specimen processing. The errors may lead to incorrect diagnoses or errors in patient management.
- Product
- CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.
- Category
- Medical Device
- Distribution
- Distributed nationwide