FDA-Device2026-10-21Class IIPROCESSING DEFECT
BioFire FilmArray Pneumonia Panel recalled for contamination risk causing false positive results
What this means
Specific lots of BioFire's FilmArray Pneumonia Panel diagnostic kits may be contaminated, which could cause false positive test results. The affected kits are used by laboratories and hospitals to test for respiratory infections. Healthcare facilities using these specific lot numbers should stop testing with them immediately.
- Check if your facility has any of the affected lot numbers (see full recall notice for complete list)
- Stop using affected kits and quarantine them
- Contact BioFire Diagnostics for replacement kits or further instructions
- Review any test results from the affected lots with your laboratory director
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
3,871
Manufactured in
515 S Colorow Dr, Salt Lake City, UT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0149-2027More BioFire Diagnostics recalls
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