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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:122201

VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) 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-0324-2014

Evidence summary

Product code
CIG
Recall status
Terminated
Event initiated
June 12, 2013
Root cause
Equipment maintenance
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0324-2014

Field note

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