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Ionify Steroids 2

Roche Diagnostics GmbH · Model 09634444160 · UDI-DI 07613336232132

JKC Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Ionify DHEA Ionify DHEA-S Ionify 17-Hydroxyprogesterone Ionify Progesterone

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2018-03-05	Tosoh Bioscience Inc	Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
2018-01-02	Siemens Healthcare Diagnostics, Inc.	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 C
2017-12-14	Abbott Gmbh & Co. KG	Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
2012-11-14	Siemens Healthcare Diagnostics, Inc	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 an
2010-09-09	Beckman Coulter Inc.	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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.