Siemens healthcare diagnostics has determined that dimension vista® blood urea nitrogen (bun) lots 15215ae, 15243bb, 15264ba, 15299bb, 15300ba, 15320bb, and 15341ac may exhibit inaccurate patient and/or quality control results.Only specific reagent cartridge wells are affected.If calibration is performed using an unaffected well and patient results are subsequently run using an affected well, bun results may be falsely depressed by up to approximately 50%.If calibration is performed using an affected well, bun results may be falsely elevated by up to approximately 64%.Siemens issued an urgent medical device correction dated february 2016, communication vc-16.01.B.Us to all u.S accounts or an urgent field safety notice vc-16-01.B.Ous, to all outside u.S.Accounts who had been shipped the impacted lots.Customers were directed to discard certain flexes with a specific lot number/cavity number combination.Siemens offered a no charge replacement or credit for discarded inventory.
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