Facility

DFI CO., LTD.

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

Key facts

1recalls · worst Class II

1inspections · worst OAI

—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)	3005841640
Establishment type	Manufacture Medical Device
Location	388-25 Gomo-Ro Gimhae Jeonnam, KR 50875
Registration status	Active · expires 2026
Parent company	DFI CO., LTD. (owner-operator 9089171)
Brand names	QTEST 11

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (10)

Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Product code JJB (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1115
Nitroprusside, Ketones (Urinary, Non-Quant.)
Product code JIN (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1435
Test, Urine Leukocyte
Product code LJX (opens in a new tab) · Class I · Hematology · 21 CFR 864.7675
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Product code JMA (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1095
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Product code CEN (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1550
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Product code CDM (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1785
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Product code JIL (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1340
Blood, Occult, Colorimetric, In Urine
Product code JIO (opens in a new tab) · Class II · Hematology · 21 CFR 864.6550
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Product code JIR (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1645
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Product code JMT (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1510

Recalls & enforcement

Class IIOngoing2026-04-02
The devices were distributed without required FDA premarket clearance or approval.

FDA inspections (1)

OAI2025-01-09
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 DFI CO., LTD.

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. “DFI CO., LTD. (FEI 3005841640) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005841640-dfi-co-ltd/

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