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NexScreen Cup

NEXSCREEN, LLC · Model 61033N · UDI-DI 00858984006040

LFG DJR JXM DIS DJC DKZ DJG DIO LDJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

THC, COC, OPI300, AMP, MET, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup

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.