FDA-Device2023-05-10Class II
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). 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
34,746 kits
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). 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-1504-2023Don't want to check this manually?
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