The cause of the flagged plasma n control results with the f viii reagent lot 44637 is unknown.Root cause investigation has been initiated and is ongoing.Manufacturer's preliminary analysis: during investigations, siemens healthcare diagnostics has observed that the above mentioned lot is showing an increased occurrence of irregular curves when used for measurement on sysmex ca-/cs- instruments.This could lead under certain circumstances to an erroneously increased result with a factor viii chromogenic assay.The use of the affected lot on the bcs/ and bcs xp system is not affected by this issue.Siemens issued an urgent field safety notice br-01216 outside the u.S and an urgent medical device correction communication ph-16-002.A.Us within the u.S.The communication, dated november 2015, was entitled higher occurrence of irregular curves with factor viii chromogenic assay lot #44637.It instructed customers who had ordered the impacted lot of factor viii chromogenic assay on a sysmex ca-1500, ca-7000 in the u.S.And also, cs-2000i, cs-2100i, or cs5100 instruments outside the u.S., to discontinue use of lot 44637.It notified customers that some patient results may show a positive bias of more than 20% over the complete measuring range and that results that cross the medical decision points might be incorrectly assessed.Further, the letter stated that due to a different detection principle, the use on bcs and bcs xp instruments is not affected and that they can continue using the product on bcs / bcs xp.Siemens healthcare diagnostics is continuing to investigate the issue.Siemens will provide an update to this report if additional information becomes available.
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