Facility

Kikuyo Factory

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

Key facts

2recalls · worst Class II

—inspections in our data

—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)	3015969360
Establishment type	Manufacture Medical Device
Location	1552-1 Aza Kazaawa, Oaza Magate, Kikuyo-machi, Kikuchi-gun Kumamoto, JP 86911
Registration status	Active · expires 2026
Parent company	IDS CO, LTD (owner-operator 10049986)
Brand names	Power Express

Activity by year

Recalls (2)

Devices registered here (5)

Radioimmunoassay, Thyroid-Stimulating Hormone
Product code JLW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1690
Acid, Folic, Radioimmunoassay
Product code CGN (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1295
Radioassay, Vitamin B12
Product code CDD (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1810
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Product code JJE (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2160
Ferritin, Antigen, Antiserum, Control
Product code DBF (opens in a new tab) · Class II · Immunology · 21 CFR 866.5340

Recalls & enforcement

Class IIOngoing2024-10-16
The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.
Class IITerminated2012-11-07
Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. The value of 24.4 ng/mL for calibrator 4 was stated on the QC report, however the correct value should have read 28.4 ng/mL…

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. “Kikuyo Factory (FEI 3015969360) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015969360-kikuyo-factory/

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