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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:188626

Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478

Official recall number

Z-2424-2021

Evidence summary

Product code
MOI
Recall status
Open, Classified
Event initiated
July 06, 2021
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2424-2021

Field note

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