Breast Milk Analyzer Lacks FDA Validation, Risks Sub-optimal Infant Nutrition
Stanbio Laboratory's Creamatocrit Plus breast milk analyzer was marketed without required FDA 510(k) clearance. Its performance has not been validated, and erroneous results could lead to inadequate nutritional supplementation for infants.
- Product
- Separation Technology Creamatocrit Plus, Catalog Number: 100-146
- Category
- Medical Device
- Distribution
- Distributed nationwide