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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:142860

ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.

Official recall number

Z-0740-2016

Evidence summary

Product code
CFR
Recall status
Terminated
Event initiated
January 11, 2016
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0740-2016

Field note

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