ClearanceBrief
Recall Z-1133-2019 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers

BioFire Diagnostics, LLC

FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

DateMar 7, 2019
StatusTerminated
ReasonIncreased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
Root causeMaterial/Component Contamination
ActionOn 03/07/19, Urgent: Medical Device Recall (Correction) notices were mailed to customers. Customers were informed that the false positive results are primarily Enterobacteriaceae results with a lower rate of concurrent E. coli results. If the affected BCID panel is used with BACT/ALERT blood culture bottles from the lots listed, then positive results for Escherichia coli and Enterobacteriaceae (if occurring without a specific genus/species reported other than E. coli; i.e. negative for all of the following: Enterobacter cloacae complex, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, and
Quantity20350
DistributionMA, NH, VT, CT, NJ, NY, PA, DE, DC, VA, MD, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, WY, ID, UT, AZ, NM, NV, CA, HI, OR, WA, AK, BM
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
Biofire Diagnostics, Inc., Jun 21, 2013
K143171FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
Biofire Diagnostics, LLC, Jan 30, 2015
K160457FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
Biofire Diagnostics, LLC, Mar 15, 2016
K181493FilmArray Blood Culture Identification (BCID) Panel
Biofire Diagnostics, LLC, Jul 5, 2018