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AUTION Check Plus Controls

ARKRAY USA, INC. · Model 102478 · UDI-DI 04987486009801

JJW Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth.

Recalls

Date	Firm	Reason
2025-11-22	Changchun Wancheng Bio-Electron Co., Ltd.	Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa
2024-09-17	Mckesson Medical-Surgical Inc. Corporate Office	The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay i
2024-07-16	Beckman Coulter, Inc.	Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results whe
2022-11-18	Beckman Coulter, Inc.	Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iC
2022-02-16	Beckman Coulter, Inc.	IRISpec CA failures for glucose.
2020-04-20	Cardinal Health Inc.	Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdi
2019-07-25	Randox Laboratories Ltd.	Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
2017-12-21	Quantimetrix Corporation	The kits contained an incorrect lot of Dropper Plus Level 1 vials
2014-02-06	Lin-Zhi International Inc	Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards t
2013-10-29	Thermofisher Scientive	Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.

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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.