LumiraDx SARS-CoV-2 Antibody Test Strip Modified Outside Approved Scope
LumiraDx recalled SARS-CoV-2 Antibody Test Strips after discovering modifications were made outside the FDA-approved Emergency Use Authorization scope. The recall affects 635 units in 13 states.
- Product
- LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
- Category
- Medical Device
- Distribution
- 13 states