Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of 510(k) Clearance
Hardy Diagnostics is recalling several microbiology media products, including BEA Agar with VGA, because they lack FDA 510(k) clearance.
- Product
- Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
- Category
- Medical Device
- Distribution
- Distributed nationwide