Siemens COVID-19 Diagnostic Assay Recalled for Inadequate Validation Data
Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.
- Product
- Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
- Category
- Medical Device
- Distribution
- Distributed nationwide