Alco-Screen02

CHEMATICS, INC. · Model 56001 · UDI-DI 00737051863109

510(k) clearances

Adverse events

Recalls

Facilities

Description

ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use. 510K Cleared - CliaWaived

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2020-02-14	Siemens Healthcare Diagnostics, Inc.	The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
2019-01-16	Carolina Liquid Chemistries	Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the e
2019-01-16	Carolina Liquid Chemistries
2019-01-11	Lin-Zhi International Inc	Shelf life of the product may be reduced due to degradation of the assay.
2010-11-01	Express Diagnostics Int'l., Inc.	Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product

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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.