Ketone and urinalysis strips recalled over missing premarket clearance
Changchun Wancheng Bio-Electron is recalling 32,500 units covering The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips because tests requiring a 510(k) were distributed before they could be legally marketed.
- Product
- The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
- Category
- Medical Device
- Distribution
- Distributed nationwide