Facility

ACON BIOTECH (HANGZHOU) CO., LTD.

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

Key facts

1recalls · worst Class III

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)	3002829675
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	No. 210 Zhenzhong Road HANGZHOU Zhejiang, CN 31003
Registration status	Active · expires 2026
Parent company	ACON Laboratories Inc. (owner-operator 9033096)
Brand names	Mission U500 Urine Analyzer

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (12)

Refractometer For Clinical Use
Product code JRE (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2800
Test, Urine Leukocyte
Product code LJX (opens in a new tab) · Class I · Hematology · 21 CFR 864.7675
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Product code CEN (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1550
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Product code JIL (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1340
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Product code JIR (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1645
Blood, Occult, Colorimetric, In Urine
Product code JIO (opens in a new tab) · Class II · Hematology · 21 CFR 864.6550
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
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
Product code NGJ (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1510
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Product code JMA (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1095
Automated Urinalysis System
Product code KQO (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2900
Nitroprusside, Ketones (Urinary, Non-Quant.)
Product code JIN (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1435
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Product code CDM (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1785

Recalls & enforcement

Class IIITerminated2015-06-17
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.

FDA inspections (1)

NAI2016-05-06
No Action Indicated · Compliance: 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.

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. “ACON BIOTECH (HANGZHOU) CO., LTD. (FEI 3002829675) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002829675-acon-biotech-hangzhou-co-ltd/

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