Z-0725-2026Class II

InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model...

Name: Z-0725-2026 InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model...
Creator: Enterix, Inc.
Published: 2025-09-17
License: https://open.fda.gov/license/

Enterix, Inc. / initiated 2025-09-17 / Open, Classified

FDA source

Enterix, Inc. began a recall of InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25... on 2025-09-17. FDA classified it as Class II and gives the reason as "InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0725-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-17
Posted: 2025-11-28
Recalling firm: Enterix, Inc.
Product: InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
Product code: KHE Reagent, Occult Blood
Reason for recall: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
FDA root cause: Under Investigation by firm
Action: Consignees were initially sent an email as notification of the recall on about 09/17/2025, which was followed by a formal recall notification letter on about 09/23/2025. Consignees were instructed to immediately examine inventory and quarantine any affected units, notify customers if affected further distributed, and for those patients that have already been tested using an InSure ONE test kit that has been identified as part of the scope of this recall be retested. Once an inventory count has been received by Enterix, they will provide RMA and courier information so the recalled product can be returned for sorting and destruction.
Quantity in commerce: 201,426 test kits
Distribution: Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.
Product codes and lots: 1. Model Number: 90010; GTIN:10850093003313; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 2. Model Number: 90025; GTIN: 20850093003310; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 3. Model Number: 90030; GTIN: 00850093003279; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0725-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0725-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-11-28

Product code KHE

K170548Class IIInSure ONEEnterix, Inc. / cleared 2017-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)