Facility

ARKRAY FACTORY USA, INC.

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

Key facts

2recalls · worst Class I

1inspections · worst NAI

—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)	1832816
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	8260 NW 27th Street Miami, FL, US 33122
Registration status	Active · expires 2026
Parent company	ARKRAY FACTORY USA, Inc. (owner-operator 8030316)
Brand names	ReliOn Premier Lancing Device; Multi-Lancet Device 2

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Multiple Use Blood Lancet For Single Patient Use Only
Product code QRL (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4850

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…

FDA inspections (1)

NAI2016-08-16
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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 USA, INC. (FEI 1832816) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1832816-arkray-factory-usa-inc/

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