medical Class II Updated 2018-05-16

Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ rea

Recalled Product

Dimension Vista¿ Thyroid Stimulating Hormone (TSH) 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: TSH, radioimmunoassay, thyroid stimulating hormone, RF612, SMN# 10464524 Lot codes: 16277BD 16322BB 17005BB 17023AC 17069AA 17093BB 17122AA 17150AA 17193BA 17215AC 17268AA
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