Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution Lot/code info: UDI-DI: (01)00630414574028(10)55972535(17)20240914; (01)00630414574028(10)55973535(17)20240914 Kit Lot: 55972535, 55973535

UPC codes

00630414574028

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.