Home › HORIBA INSTRUMENTS INCORPORATED › Pointe Ethyl Alcohol Reagent Set

Pointe Ethyl Alcohol Reagent Set

HORIBA INSTRUMENTS INCORPORATED · Model 60-EA0440-1L · UDI-DI 00811727017406

DIC Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Pointe Ethyl Alcohol Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.