Facility
ACON LABORATORIES, INC.
1 recall(s) on record — most severe on record: Class III.
| FDA Establishment Identifier (FEI) | 3003516723 |
|---|---|
| Establishment type | Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | 9440 Carroll Park Dr SAN DIEGO, CA, US 92121 |
| Registration status | Active · expires 2026 |
| Parent company | ACON Laboratories, Inc. (owner-operator 9063887) |
| Brand names | Flowflex COVID-19 Antigen Home Test |
Devices registered here (1)
- Over-The-Counter Covid-19 Antigen TestProduct code QYT · Class II · Microbiology · 21 CFR 866.3984
Recalls & enforcement
- Class IIITerminated2015-06-17Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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