The customer contacted the siemens customer care center questioning the higher results obtained on the bcs xp relative to other non-siemens systems.Siemens headquarters support center (hsc) representatives have evaluated the information provided.Hsc concluded that review of all available information gives no indication of a systemic issue with the bcs xp system, reagent material, or laboratory practices at the customer laboratory.Routine quality control as well as prior survey samples recover acceptably.An overall problem with the fviii % activity application with actin fsl on the bcs xp system can be excluded.Patient comparisons have been conducted and demonstrate acceptable comparison for fviii % activity between the alternate vendor methods (non-siemens).Recovery of the samples fviii % activity on an alternate instrument system with actin fsl reagent and factor viii deficient plasma also was consistent with the bcs xp system recovery.Additionally, comparison across various lots of actin fsl compare well.Comparison of multiple external quality assessment survey vendor samples do not demonstrate a systemic bias.A clear difference in recovery with this specific sample is demonstrated between the application of siemens fviii with actin fsl on the bcsp xp as compared to competitors systems.The patient had received helixate fs product (recombinant factor viii concentrate) prior to collection of this sample.The recovery with siemens products is believed to be accurate for the sample provided to the laboratory for analysis.A false low bias is believed to be demonstrated with the alternate vendor products.The customer has confirmed that no irreparable harm was caused to the patient based upon the original value reported.The device is performing within specifications.No further evaluation of the device is required.
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