Biofire Diagnostics, Llc: Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System
Recall Summary BioFire Diagnostics is recalling specific lots of FilmArray Pneumonia Panel plus test kits due to potential contamination that could produce false positive results for respiratory pathogens. The affected kits (model numbers RFIT-ASY-0143 and RFIT-ASY-0142) were distributed nationwide in the U.S. and internationally. This is classified as a Class II recall, meaning the product could cause health problems but is unlikely to cause serious injury.
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- Generic Name: FilmArray Pneumonia Panel plus Generic Name: FilmArray Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
- Reason
- Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states and territory of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/90d56236-9629-4f4e-ae72-bbccd6839bd6