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 healthcare diagnostics confirmed additional complaints and has added additional blood urea nitrogen (bun k1021) lots 16004ab, 16034aa, 16033ac, 16048aa, 16055aa, 16055ab,16062aa, 16062ab as well as all future vista bun lots until further notice to the field action.An updated information communication umdc vc-16-01a.B.Us and ufsn vc-16-01a.B.Ous has been mailed in june 2016 to all accounts who have been shipped these lots.All new vista bun customers will receive a copy of the umdc/ufsn until affected product is depleted from inventory.The communication advised customers to follow the additional instructions under the section "actions to be taken by the customer" to manage their bun testing.(b)(4).
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