Medical Device Test Kit Requires More Frequent Calibration Than Labeled
Siemens Atellica IM BR 27.29 test kit requires calibration every 3 days instead of the labeled 10-day interval. The product's calibration performance does not meet its Instructions for Use specifications.
- Product
- Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
- Category
- Medical Device
- Distribution
- Distributed nationwide