Siemens IMMULITE Testosterone Assay Recalled for Measurement Bias
Siemens is recalling two lots of its IMMULITE Total Testosterone Assay due to a confirmed 40% positive measurement bias at higher testosterone levels, which may delay diagnosis and require repeat testing.
- Product
- IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.
- Category
- Medical Device
- Distribution
- Distributed nationwide