Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur¿ DHEA-SO4

Recall date

January 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1688-2018

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Nationwide and Canada, Mexico, and Thailand

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ADVIA Centaur¿ DHEA-SO4