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)
Check against the official notice below — it lists the full affected range.
BioFire Diagnostics, LLC is recalling FilmArray Pneumonia Panel test kits (Part Nos. RFIT-ASY-0144 and RFIT-ASY-0145) due to real-time stability study failures that resulted in an increased rate of false negative results between the 6 to 12 month expiry time-frame. A total of 4,462 kits were distributed globally, including throughout the United States, U.S. territories, and numerous countries internationally.
The recall affects test kits with the specified part numbers and UDI codes. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
Reason for recall: Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. Distribution: 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, Colombi Quantity: 4,462 kits (Globally) Lot/code info: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.