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AUTION MAX™ AX-4060 Analyzer

ARKRAY USA, INC. · Model 110732 · UDI-DI 00015482117313

JIL Prescription

510(k) clearances

547

Adverse events

Recalls

Facilities

Description

The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis sytem intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2024-04-04	Macherey Nagel Gmbh & Co. Kg	The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Sc
2016-07-15	Roche Diagnostics Operations, Inc.	Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has be
2014-12-08	Beckman Coulter Inc.	Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
2014-09-19	Siemens Healthcare Diagnostics, Inc	The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
2014-09-19	Siemens Healthcare Diagnostics, Inc	The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
2014-09-19	Siemens Healthcare Diagnostics, Inc	The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

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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.