ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239

Reason: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

Code information: UDI-DI: (01)00630414574257(10)55970535(17)20240914; (01)00630414574257(10)55971535(17)20240914 Kit Lot: 55970535, 55971535

Distribution pattern: Worldwide - US Nationwide distribution