Facility

KAMIYA BIOMEDICAL COMPANY LLC

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

Key facts

2recalls · worst Class II

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)	2084025
Establishment type	Repack or Relabel Medical Device
Location	12779 Gateway Dr S Tukwila, WA, US 98168
Registration status	Active · expires 2026
Parent company	KAMIYA BIOMEDICAL COMPANY LLC (owner-operator 9001370)
Brand names	K-ASSAY(R) Ferritin Calibrator; K-ASSAY(R) Ferritin

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (2)

Ferritin, Antigen, Antiserum, Control
Product code DBF (opens in a new tab) · Class II · Immunology · 21 CFR 866.5340
Calibrator, Secondary
Product code JIT (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1150

Recalls & enforcement

Class IIOngoing2022-09-28
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Class IITerminated2017-07-19
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.

FDA inspections (1)

NAI2024-05-16
No 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.

All facilities operated by KAMIYA BIOMEDICAL COMPANY LLC

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. “KAMIYA BIOMEDICAL COMPANY LLC (FEI 2084025) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2084025-kamiya-biomedical-company-llc/

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