FilmArray 2.0 Diagnostic Instruments Recalled for Calibration Error Affecting Test Results
BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.
- Product
- FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
- Category
- Medical Device
- Distribution
- Distributed nationwide