FDA-Device2023-05-10Class II
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
Siemens Healthcare Diagnostics, Inc.
Hazard
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Sold states
Worldwide distribution - US Nationwide.
Affected count
18,961 kits
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1505-2023Don't want to check this manually?
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