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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:168908

Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

Official recall number

Z-0624-2019

Evidence summary

Product code
GKA
Recall status
Terminated
Event initiated
November 01, 2018
Root cause
No Marketing Application
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0624-2019

Field note

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