FDA Class I Recall: Thermo Sensititre Gram Negative Diagnostic Test Inaccuracy
Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.
- Product
- Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
- Category
- Medical Device
- Distribution
- Distributed nationwide