Device evidence

device-recall:cfres:209486

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

Official recall number

Z-3103-2024

Evidence summary

Product code: NIG
Recall status: Open, Classified
Event initiated: July 26, 2024
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-3103-2024