Unauthorized SARS-CoV-2 Antigen Tests recalled for lack of FDA clearance
WHPM Inc. is recalling approximately 535,755 First SIGN SARS-CoV-2 Antigen Tests distributed in California, Florida, Louisiana, Massachusetts, and Texas. The tests were sold without FDA Emergency Use Authorization or clearance.
- Product
- First SIGN SARS-CoV-2 Antigen Test
- Category
- Medical Device
- Distribution
- 5 states