Dimension Vista System - Ca15-3 Flex Reagent Cartridge

Siemens Healthineers has received customer complaints for negative patient bias with the Dimension Vista Loci Ca15-3 assay. Siemens has confirmed the Dimension Vista Loci Ca15-3 lots show a negative bias with patient samples. The mean patient sample bias for the lots listed range from -26% to -33%. Patient bias is consistent across the analytical measurement range (AMR). The highest bias observed on a patient sample (56 u/ml) was - 47%. Quality control does not detect this issue

Recall start date: July 26, 2022