medical Class II Updated 2018-05-16

Siemens Healthcare Diagnostics, Inc. recalls Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent

Recalled Product

Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: TSHL, radioimmunoassay, thyroid-stimulating hormone, RF612, SMN# 10464524 Lot codes: EB7276 EC7298 EA7318 EB7346 EC7346 EA8012 EA8033 EA8051 EC8080 EB8107 EB8121 EA8143 EB8143 EA8177 EB8177 EB8199 EA8223 EA8241 EA8261

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