Azure Biotech Recalls Assure COVID-19 Rapid Test Devices for Labeling Errors
Azure Biotech Inc. is recalling 100,000 Assure COVID-19 IgG/IgM Rapid Test Devices due to incorrect diagnostic labeling and unsupported expiration dating.
- Product
- Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Tes
- Category
- Medical Device
- Distribution
- Distributed nationwide