Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

DHEA Test

Distribution without premarket approval/clearance.

Fructose Intolerance Test

Distribution without premarket approval/clearance.

ADVIA Centaur DHEA-SO4

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

Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS)

Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.

DHEA RIA Reagent

The recall was initiated because Beckman Coulter has confirmed customer reports that DHEA measurements using DHEA RIA (REF DSL-8900) kit lots identified may overstate actual DHEA levels in patient samples.

ARCHITECT DHEA-S Reagent

Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.

ST-AIA DHEA-S; Part Number: 025222

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.