The initial mdr 2517506-2016-00369 was filed on october 20, 2016.Additional information (02/28/2017): siemens healthcare diagnostics has confirmed that in isolated cases when ecrea is processed immediately after the weekly automated acid clean routine during probe test, there is the remote potential for an elevation of greater than 15 percent in the ecrea result.While siemens understands that customers routinely run quality control (qc) after system maintenance, it is particularly important to run ecrea qc after the probe test to identify a potential elevated ecrea result.Customers in the united states were sent urgent medical device correction (umdc) vs-17-01.A.Us and customers outside the united states were sent urgent field safety notice (ufsn) vs-17-01.A.Ous in march 2017.The umdc and ufsn are entitled "elevated enzymatic creatinine (ecrea) results following dimension vista acid clean (acln) routine." the umdc and ufsn explain the issue, the risk to health, and the actions to be taken by the customer.
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