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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:188892

DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118

Official recall number

Z-2602-2021

Evidence summary

Product code
JJE
Recall status
Terminated
Event initiated
July 21, 2021
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2602-2021

Field note

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