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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:127317

cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

Official recall number

Z-1792-2014

Evidence summary

Product code
JJE
Recall status
Terminated
Event initiated
May 21, 2014
Root cause
Labeling design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1792-2014