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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:147904

The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.

Official recall number

Z-2247-2016

Evidence summary

Product code
LDT
Recall status
Terminated
Event initiated
June 27, 2016
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2247-2016