FDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk
Thera Test Laboratories is recalling EL-Anti-SARS-CoV-2 IgG kits due to cross-reactivity that may produce false positive results. The recalled lot numbers are 05204351 and 05204368, affecting distribution in six US states.
- Product
- EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
- Category
- Medical Device
- Distribution
- Distributed nationwide