Facility

HEALGEN SCIENTIFIC LLC

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

Key facts

1recalls · worst Class II

1inspections · worst VAI

—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)	3009238284
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	3818 Fuqua St Houston, TX, US 77047
Registration status	Active · expires 2026
Parent company	HEALGEN SCIENTIFIC LLC (owner-operator 10038461)
Brand names	Healgen Rapid Check RSV Antigen Test Cassette

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Product code GQG (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3480

Recalls & enforcement

Class IIOngoing2024-08-22
The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of urinary protein by way of uneven color fading on the total protein test pad. Thi…

FDA inspections (1)

VAI2016-11-02
Voluntary Action Indicated · Compliance: 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 HEALGEN SCIENTIFIC LLC

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. “HEALGEN SCIENTIFIC LLC (FEI 3009238284) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009238284-healgen-scientific-llc/

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