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EZ-SCREEN® CUP

MEDTOX DIAGNOSTICS, INC. · Model 605102 · UDI-DI 00690286000438

DIS DJR JXM DKZ DJG DJC DIO LCM LDJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, Benzodiazepines, Methadone, Barbiturates, Oxycodone, and Buprenorphine drugs and/or their metabolites in human urine.

Recalls

Date	Firm	Reason
2019-06-12	Beckman Coulter Inc.	The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compo
2018-05-18	Guangzhou Wondfo Biotech Co., Ltd.	GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collect
2018-05-18	Guangzhou Wondfo Biotech Co., Ltd.	GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collect
2018-05-18	Guangzhou Wondfo Biotech Co., Ltd.	GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collect
2016-11-10	OraSure Technologies, Inc.	Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
2012-01-04	Alere San Diego	Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.
2011-09-08	Lin-Zhi International Inc	Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correc

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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.