The Xpert Carba-R QC Panel M219 is intended for in vitro use as a quality control to monitor the detection and differentiation of 5 beta-lactamase gene sequences (blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP-1) when tested by the Cepheid Xpert Carba-R Assay on the GeneXpert instrument. The gene sequences are associated with carbapenem-non-susceptibility in gram-negative bacteria. The Xpert Carba-R QC Panel M219 is comprised of 12 tubes, 50µL each of synthetic DNA encapsulated in chemically killed and fixed, nonpathogenic bacterial cells, suspended in buffer and preservative. Six (6) of the tubes are Xpert Carba-R Positive Control, which carries all 5 beta-lactamase gene sequences. The other 6 tubes are Xpert Carba-R Negative Control which does not carry any beta-lactamase gene sequences.