FDA-Device2026-10-21Class IIPROCESSING DEFECT
BioFire FilmArray Pneumonia Panel recalled for potential contamination causing false positive results
What this means
Specific lots of BioFire's FilmArray Pneumonia Panel diagnostic kits may be contaminated, which could cause the test to incorrectly identify pathogens as present when they are not. This affects laboratory tests used to diagnose respiratory infections. The contamination was identified in 57 lot numbers distributed worldwide, including across the United States.
- If you operate a laboratory or clinic using affected lot numbers, contact BioFire Diagnostics immediately for instructions
- Check your inventory against the list of 57 affected lot numbers provided by the FDA
- Do not use kits from recalled lots for patient testing until you receive guidance from BioFire or your healthcare authority
- Review any test results from affected lots with your laboratory supervisor or infectious disease team
The agency's original wording
Hazard
Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
Intended for
All ages
Illnesses reported
None reported
Sold states
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 United Arab Emirates, Netherland Antilles, Argentina, Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Bolivia, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Indonesia, Israel, India, Italy, Japan, Korea, Lebanon, Sri Lanka, Lithuania, Mexico, Malaysia, Nicaragua, Panama, Peru, Philippines, Poland, Portugal, Paraguay, Romania, Serbia, Singapore, El Salvador, Thailand, Taiwan, Venezuela, Vietnam.
Affected count
4,892
Manufactured in
515 S Colorow Dr, Salt Lake City, UT, United States
Products
Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0148-2027More BioFire Diagnostics recalls
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