FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit) Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
Check against the official notice below — it lists the full affected range.
BioFire Diagnostics, LLC is recalling FilmArray Pneumonia Panel plus (Pneumoplus) test kits due to real-time stability study failures that resulted in an increased rate of false negative results between the 6 to 12 month expiry timeframe. The affected products include Part Numbers RFIT-ASY-0143 and RFIT-ASY-0142 (with corresponding UDIs 00815381020314 and 00815381020321). A total of 3,559 kits have been recalled globally.
The recalled kits were distributed throughout the United States, including all 50 states, Washington D.C., Guam, and Puerto Rico, as well as internationally to numerous countries. 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: 3,559 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.