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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:118364

VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Official recall number

Z-1614-2013

Evidence summary

Product code
CEM
Recall status
Terminated
Event initiated
May 09, 2013
Root cause
Employee error
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1614-2013

Field note

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