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AUTION™ MAX AX-4030 Analyzer

ARKRAY USA, INC. · Model 14505 · UDI-DI 00015482145057

KQO

510(k) clearances

1,091

Adverse events (1 deaths)

Recalls

Facilities

Description

Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity.

Recalls

Date	Firm	Reason
2026-08-12	Beckman Coulter, Inc.	The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replace
2026-08-12	Beckman Coulter, Inc.	The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replace
2023-04-05	Beckman Coulter, Inc.	Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have
2023-04-05	Beckman Coulter, Inc.	Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have
2023-04-05	Beckman Coulter, Inc.	Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have be
2023-04-05	Beckman Coulter, Inc.	Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have
2021-10-18	Roche Diagnostics Operations, Inc.	A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinin
2020-03-30	Beckman Coulter Inc.	A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or me
2020-03-30	Beckman Coulter Inc.	A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or mel
2020-02-17	Beckman Coulter, Inc.	The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.

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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.