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AIMSCREEN MULTIDRUG 12

GERMAINE LABORATORIES, INC · Model 40135 · UDI-DI 00695684401351

LFG JXN DIS LCM JXM DKZ DJG LAF DIO LDJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Marijuana (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazpines (BZD), Ecstasy (MDMA) , Oxycodone (OXY), Propoxyphene (PPX).

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.