Reported Dec 10, 2025 · Ongoing
InSure ONE Fecal Immunochemical Test. Labeled as follows
Enterix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Enterix, Inc. · 236 Fernwood Ave · Edison, NJ · 08837-3839
Is this the product you have?
InSure ONE Fecal Immunochemical Test. Labeled as follows
3 of 3 products
| Model / number | Product as published |
|---|---|
90010. | Insure ONE POL Patient Kit - 10 pack. |
90025. | Insure ONE POL Patient Kit - 25 Pack. |
90030. | InSure ONE POL Combo Pack. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. |
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 10850093003313Model Number: 90010; ; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 20850093003310Model Number: 90025; ; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 00850093003279Model Number: 90030; ; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. - Amount recalled
- 201,426 test kits
Where it was sold
Why it was recalled
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
This product could cause temporary or reversible health problems — stop using it.
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