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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:146458

Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture

Official recall number

Z-1911-2016

Evidence summary

Product code
LHJ
Recall status
Terminated
Event initiated
February 19, 2016
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1911-2016

Field note

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