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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:183153

AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

Official recall number

Z-2965-2020

Evidence summary

Product code
JIF
Recall status
Terminated
Event initiated
July 30, 2020
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2965-2020