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PROFILE-II ER®

MEDTOX DIAGNOSTICS, INC. · Model 601684 · UDI-DI 00690286000780

LFG DJR DIS JXM DKZ DJG DJC DIO LCM DKE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Phencyclidine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) and Oxycodone drugs and/or metabolites in human urine.

Recalls

Date	Firm	Reason
2026-06-26	Siemens Healthcare Diagnostics, Inc.	out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall h
2003-11-17	Abbott Health Products, Inc.	Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.

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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.