RegWardenFDA facility compliance records
Facility

AFFYMETRIX, INC.

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2016: 1 inspections; 2020: 1 recalls1201620172018201912020202120222023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Instrumentation For Clinical Multiplex Test Systems
    Product code NSU (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.2570

Recalls & enforcement

  • Class IITerminated2020-08-06
    COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.

FDA inspections (1)

  • NAI2016-03-15
    No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: 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.

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. “AFFYMETRIX, INC. (FEI 3003314809) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003314809-affymetrix-inc/

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