Our current information demonstrates the assay is not reporting false results.We are continuing to investigating as quickly and diligently as possible to confirm the source of this issue and determine the root cause.As this time, other lots have not been implicated; however, in the interest of safety, we are including the intact-pth lots 2488, 2494, and 2494b in this notice.Lot 2494b is bulk shipment of the same component lots as packaged in kit lot 2494.
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The potential issue is associated with high background being observed for calibrator a.Elevated optical density (od 450 nm) of calibrator a may cause loss of separation between calibrators a and b, which may impact the assay calibration.Loss of separation was observed from kit lot 2494, 2494b.
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