medical Class II Updated 2018-05-16

Siemens Healthcare Diagnostics, Inc. recalls Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge

Recalled Product

Dimension¿ Free Thyroxine (FT4L) 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: FT4L, radioimmunoassay, free thyroxime, RF610, SMN# 10464523 Lot codes: EA7276 EC7304 EC7333 EA7346 EB8010 EA8037 EA8065 EB8086 EB8108 EA8130 EA8156 EA8179 EA8205 EA8233 FD8254
View official government recall

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