The initial reporter stated they received discrepant results for two patient samples tested with the elecsys vitamin d total gen.2 assay on a cobas 8000 e 602 module.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.No units of measure were provided.The samples were initially tested using the vitamin d gen.2 assay and were frozen after measurement.The samples were then thawed to use as part of a validation study for the vitamin d gen.3 assay and were repeated using both the gen.2 and gen.3 assays.The measurements performed with the frozen/thawed sample were lower compared to the initial measurements.The vitamin d gen.3 assay or similar device is not cleared or approved for use in the united states.The first sample initially resulted in a vitamin d gen.2 value of 128 and then the sample was frozen.The sample was thawed and repeated using the gen.2 assay, resulting in a values of 91.6.The thawed sample was repeated using the gen.2 assay on a second analyzer, resulting as 78.6.The thawed sample was repeated using the gen.3 assay, resulting in a value of 83.9.The second sample initially resulted in a vitamin d gen.2 value of 157 and then the sample was frozen.The sample thawed and repeated using the gen.2 assay on a second analyzer, resulting in a value of 95.1.The thawed sample was repeated using the gen.3 assay, resulting in a value of 91.2.The e 801 analyzer serial number is (b)(4).
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