Facility

ARKRAY Factory, Inc.

2 recall(s) on record — most severe on record: Class I.

Key facts

2recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003422726
Establishment type	Manufacture Medical Device
Location	1480 Koji, Konan-cho Koka-shi Shiga, JP 52033
Registration status	Active · expires 2026
Parent company	ARKRAY FACTORY USA, Inc. (owner-operator 8030316)
Brand names	AUTION EYE AI-4510

Activity by year

Recalls (2)

Devices registered here (2)

Automated Urinalysis System
Product code KQO (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2900
Counter, Urine Particle
Product code LKM (opens in a new tab) · Class II · Hematology · 21 CFR 864.5200

Recalls & enforcement

Class IITerminated2019-05-03
This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due …
Class ITerminated2015-12-18
One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose val…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ARKRAY Factory, Inc. (FEI 3003422726) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003422726-arkray-factory-inc/

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