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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:182570

Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection by detecting effector T cells that respond to stimulation by M. tuberculosis antigens ESAT-6 and CFP10, and capturing interferon-gamma in the vicinity of these cells.

Official recall number

Z-2977-2020

Evidence summary

Product code
OJN
Recall status
Terminated
Event initiated
July 16, 2020
Root cause
Labeling False and Misleading
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2977-2020