BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No

Recalled July 14, 2021 · FDA recall Z-2039-2021 · BioFire Diagnostics

Hazard

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. · FDA Class II

Units

4,462 kits (Globally)

Sold at

U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Algeria, Angola, Anguilla, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece , Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nicaragua, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.

Description

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

Product

FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)

Manufacturer(s)

BioFire Diagnostics, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →