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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:125895

VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

Official recall number

Z-1648-2014

Evidence summary

Product code
KLI
Recall status
Terminated
Event initiated
February 20, 2014
Root cause
Other
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1648-2014