Facility

Acon Biotech (Hangzhou) Co., Ltd.

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

Key facts

1recalls · worst Class III

—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)	3032171519
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Building 3 and Building 11, No. 33 Shidi Street, Qingshanhu Subdistrict, Linan District Hangzhou Zhejiang, CN 31130
Registration status	Active · expires 2026
Parent company	ACON Laboratories Inc. (owner-operator 9033096)

Activity by year

Recalls (1)

Devices registered here (1)

Over-The-Counter Covid-19 Antigen Test
Product code QYT (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3984

Recalls & enforcement

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

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 3032171519) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3032171519-acon-biotech-hangzhou-co-ltd/

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