Medical device test system recalled for decreased reactivity and false-negative results
Greer Laboratories recalled a hypersensitivity pneumonitis test kit (102 units, Lot 389592) after stability testing revealed decreased reactivity that could cause false-negative results. The issue was discovered in October 2021.
- Product
- GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
- Category
- Medical Device
- Distribution
- 11 states