COVID-19 diagnostic test distributed outside certified laboratory channels
CareStart COVID-19 Antigen Rapid Diagnostic Test units were distributed to non-CLIA-certified customers, violating the product's Emergency Use Authorization requirements.
- Product
- CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by…
- Category
- Medical Device
- Distribution
- Distributed nationwide