Facility

ENTERIX PTY LTD.

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

Key facts

2recalls · 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)	3005311019
Establishment type	Manufacture Medical Device
Location	UNIT 15/2 EDEN PARK DRIVE NORTH RYDE New South Wales, AU 2113
Registration status	Active · expires 2026
Parent company	Enterix Inc (owner-operator 9042500)
Brand names	InSure ONE

Activity by year

Recalls (2)

Devices registered here (1)

Reagent, Occult Blood
Product code KHE (opens in a new tab) · Class II · Hematology · 21 CFR 864.6550

Recalls & enforcement

Class IIOngoing2025-09-17
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Class IITerminated2020-10-08
Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy

All facilities operated by Enterix 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. “ENTERIX PTY LTD. (FEI 3005311019) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005311019-enterix-pty-ltd/

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