BioFire Diagnostics, LLC recalls
4 recalls on record · FDA
Every recall we have on record for BioFire Diagnostics, LLC, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test…
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only…
Their is a potential for false positive results when using Pneumonia panel.
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test…
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.