Dimension Vista System - Ca15-3 Flex Reagent Cartridge
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
---|---|---|
Dimension Vista System - Ca15-3 Flex Reagent Cartridge |
21340BB |
10464344 |
Issue
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
Additional information
Details
Siemens Healthcare Diagnostics Inc.
500 Gbc Drive, Newark, Delaware, United States, 19714