Fecal immunochemical tests recalled over the potential for false negative results

Plain-English summary

The InSure ONE Fecal Immunochemical Test, a test that qualitatively detects human hemoglobin from blood in fecal samples, is being recalled. Affected labelling covers the InSure ONE POL Patient Kit 10 pack, model 90010; the InSure ONE POL Patient Kit 25 pack, model 90025; and the InSure ONE POL Combo Pack, model 90030.

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

The recall covers 201,426 test kits: model 90010 with GTIN 10850093003313, model 90025 with GTIN 20850093003310 and model 90030 with GTIN 00850093003279, all lots produced from 7/23/2025 to 9/12/2025 with test card lot TT241102. Distribution was worldwide, including nationwide in the United States across California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington and West Virginia, and to the Philippines. The FDA has classified the action as Class II.

A false negative result on a screening test can leave blood in a stool sample undetected. Providers should follow Enterix's instructions, and patients with questions about a recent result should contact the clinician who ordered the test.

The recalled product

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 immunochemica

Manufacturer

Enterix, Inc.

Category

Medical Device — Diagnostic test

Hazard

• false-negative
• sensitivity-failure
• screening-test

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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