Facility

DIAGNOS 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)	3009422347
Establishment type	Manufacture Medical Device
Location	7005 Taschereau Blvd. Brossard Quebec, CA J4Z1A7
Registration status	Active · expires 2026
Parent company	Diagnos Inc. (owner-operator 10057825)
Brand names	CARA

Activity by year

Recalls (1)

Devices registered here (1)

System, Image Management, Ophthalmic
Product code NFJ (opens in a new tab) · Class II · Radiology · 21 CFR 892.2050

Recalls & enforcement

Class IITerminated2022-01-11
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.

All facilities operated by Diagnos 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. “DIAGNOS INC. (FEI 3009422347) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009422347-diagnos-inc/

Not open yet

Alerts for DIAGNOS INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.