Siemens filed the initial mdr 1219913-2016-00264 on january 04, 2017.On 01/05/2016 correction: the date of event was (b)(6) 2016.The date received by the manufacturer was 12/15/2016.On 01/06/2016 additional information: the advia centaur testosterone ii (tstii) assay has been aligned to the cdc hormone standardization (host) program.Tstii also demonstrates improved lower end sensitivity and precision.Customers will observe a difference in results based on these changes.The customer should expect low patient values to run lower on tstii and high patient values to run higher on tstii.Internal correlation data (n=128 in range of 8.60-1394 ng/dl) demonstrates an overall bias of <10%.The data generated by siemens is similar to what's been represented in the customer data.The tstii assay is also standardized to the cdc lc-ms/ms method.Customer bulletin 11222821, rev.B, introducing the advia centaur testosterone ii and standardized shbg assays on the advia centaur, xp and xpt systems was issued september 2016.The instrument is performing within specifications.No further evaluation of the device is required.
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