BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILM

Hazard / Issue

Due to manufacturing issue, panels may result in false negative results.

Issued by

FDA

Affected States: CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, TN, UT, WV

Lot/Code Info: Pouch Lot # 2MRG22 Kit # 2118722 Exp. 12-Nov-23, Pouch Lot # 2N0Z22 Kit # 2151022 Exp. 20-Nov-23, Pouch Lot # 2N1622 Kit # 2151722 Exp. 20-Nov-23, Pouch Lot # 2N1B22 Kit # 2152222 Exp. 20-Nov-23, Pouch Lot # 2N1D22 Kit # 2152422 Exp. 20-Nov-23, Pouch Lot # 2N1G22 Kit # 2152722 Exp. 21-Nov-23, Pouch Lot # 2N2122 Kit # 2154622 Exp. 20-Nov-23, Pouch Lot # 2N2322 Kit # 2154822 Exp. 20-Nov-23, Pouch Lot # 2N2522 Kit # 2155022 Exp. 19-Nov-23, Pouch Lot # 2N2P22 Kit # 2156822 Exp. 23-Nov-23, Pouch Lot # 2N2T22 Kit # 2157222 Exp. 21-Nov-23, Pouch Lot # 2N3022 Kit # 2157922 Exp. 22-Nov-23, Pouch Lot # 2N3222 Kit # 2158122 Exp. 20-Nov-23, Pouch Lot # 2N4C22 Kit # 2162522 Exp. 23-Nov-23, Pouch Lot # 2N4D22 Kit # 2162622 Exp. 23-Nov-23, Pouch Lot # 2N4H22 Kit # 2163022 Exp. 27-Nov-23, Pouch Lot # 2N4Z22 kit # 2164622 Exp. 23-Nov-23, Pouch Lot # 2N5K22 Kit # 2166622 Exp. 23-Nov-23, Pouch Lot # 2N5Y22 Kit # 2167922 Exp. 23-Nov-23, Pouch Lot # 2N6122 Kit # 2168222 Exp. 27-Nov-23, Pouch Lot # 2N6222 Kit # 2168322 Exp. 22-Nov-23, Pouch Lot # 2N6R22 Kit # 2170622 Exp. 23-Nov-23, Pouch Lot # 2N6S22 Kit # 2170722 Exp. 23-Nov-23, Pouch Lot # 2N6W22 Kit # 2171122 Exp. 21-Nov-23, Pouch Lot # 2N6X22 Kit # 2171222 Exp. 22-Nov-23, Pouch Lot # 2N7422 Kit # 2171922 Exp. 26-Nov-23, ;UDI-DI: UDI: 00815381020482