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Siemens Healthcare Diagnostics, Inc. recalls Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
Recalled May 16, 2018 · FDA recall Z-1668-2018 · Siemens Healthcare Diagnostics
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. · FDA Class II
Units
N/A
Sold at
Nationwide and Canada, Mexico, and Thailand
Description
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.
Product
Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →