Facility

INOVA DIAGNOSTICS, INC.

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

Key facts

1recalls · worst Class II

—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)	2026994
Establishment type	Manufacture Medical Device
Location	9900 Old Grove Rd SAN DIEGO, CA, US 92131
Registration status	Active · expires 2026
Parent company	INOVA DIAGNOSTICS, INC. (owner-operator 2026994)
Brand names	QUANTA Lite Gliadin IgA ELISA Bulk Pack; QUANTA Lite Gliadin IgA ELISA

Activity by year

Recalls (1)

Devices registered here (1)

Antibodies, Gliadin
Product code MST (opens in a new tab) · Class II · Immunology · 21 CFR 866.5750

Recalls & enforcement

Class IITerminated2018-01-26
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.

All facilities operated by INOVA DIAGNOSTICS, INC.

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. “INOVA DIAGNOSTICS, INC. (FEI 2026994) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2026994-inova-diagnostics-inc/

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