A siemens headquarter support center (hsc) specialist evaluated the instrument data.When the work-order for the sample in question was downloaded to the automation system it did not have the correct sample type (came in as "default"), and therefore the centrifuge pre-test was not assigned by the automation system to this sample.The automation system performed as expected.A siemens service personnel was dispatched to the customer site, and added a centrifuge pre-test in addition to sample type.Siemens healthcare diagnostics has determined that there is a remote possibility centralink may download an order to the advia automation system without specifying the sample type.This can occur when an order is received from the laboratory information system (lis) without a sample type, requiring that the sample type be set in centralink based on the sample type of the test in the order.Urgent medical device correction (umdc) (b)(4) was sent to customers in the united states in (b)(6) 2016 and corresponding urgent field safety notice (b)(4) to all outside us centralink® data management system customers.The umdc and ufsn are entitled "sample type may not download to advia® labcell or advia® workcell automation systems." the umdc and ufsn explain that if the automated task to download samples to the laboratory automation system (las) processes immediately after the order is received from the lis, there is a possibility that a test may be downloaded before the sample type on the sample record is set.On advia automation, the value "default" will be downloaded instead of the sample type value.This issue may affect advia automation systems that have activities based on sample type.Siemens recommends the lis specify the sample type in the work order.
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