DNA GENOTEK, INC.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (1)
Devices registered here (1)
- Dna Specimen Collection, SalivaProduct code OYJ (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1675
Recalls & enforcement
- Class IIOngoing2022-02-18Evaporation of stabilizing liquid reducing shelf life.
- Class IIITerminated2020-06-24Reagents were shipped to customers after the Use by data indicated on its labeling.
FDA inspections (1)
- VAI2016-11-03Voluntary Action Indicated · Compliance: Devices; 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. “DNA GENOTEK, INC. (FEI 3003742580) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003742580-dna-genotek-inc/
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