medical Class II Updated 2018-05-16

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

Recalled Product

ADVIA Centaur¿ DHEA-SO4


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: ADVIA Centaur¿ DHEA-SO4; radioimmunoassay, dehydroepiandrosterone (free and sulfate); SMN 10282227 ADVIA Centaur DHEA-S Kit Lot # 00119053 14041053 80449053 90520053 29750054 30423054 39155054 50533054 63267055 68936055 79273055 86427055 06402057 07109057 14187057 37499057
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