Kidney tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 100 units of its Kidney Test because the product was distributed without premarket approval or clearance.
- Product
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
- Category
- Medical Device
- Distribution
- Distributed nationwide