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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:185046

VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292

Official recall number

Z-0844-2021

Evidence summary

Product code
CEK
Recall status
Terminated
Event initiated
December 15, 2020
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0844-2021

Field note

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