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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:122198

VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Official recall number

Z-0321-2014

Evidence summary

Product code
DIP
Recall status
Terminated
Event initiated
June 12, 2013
Root cause
Equipment maintenance
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0321-2014

Field note

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