RegWardenFDA facility compliance records
Facility

ARKRAY, INC.

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

Activity by year

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

Devices registered here (1)

  • Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
    Product code LXG (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2050

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…

Related

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, INC. (FEI 3002807423) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807423-arkray-inc/

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