FDA-Device2018-05-16Class II
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
Siemens Healthcare Diagnostics, Inc.
Hazard
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.
Sold states
Nationwide and Canada, Mexico, and Thailand
Affected count
N/A
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1673-2018Don't want to check this manually?
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