RegWardenFDA facility compliance records
Company

ARKRAY FACTORY USA, Inc.

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

Recalls by year

FDA actions on record by year2015: 1 recalls; 2019: 1 recalls12015201620172018120192020202120222023202420252026
  • Recalls (2)

Registered facilities (3)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “ARKRAY FACTORY USA, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8030316-arkray-factory-usa-inc/

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