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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:195370

Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456

Official recall number

Z-1648-2022

Evidence summary

Product code
MOI
Recall status
Open, Classified
Event initiated
July 18, 2022
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1648-2022