Roche received customer complaints alleging the generation of false negative influenza a (flu a) results and late flu a target CT values when using the Cobas® Cars-Cov-2 & influenza a/b qualitative for use on Cobas® 6800/8800 systems. These allegations are specific to recently circulating mutations (single or double mutation) in h1n1pdm09 pertinent to the region of interest of the aforementioned test. Recall start date: December 22, 2022
RecallTracker