Enterix recalls InSure ONE fecal immunochemical test kits that may produce false negative results when used with Test Card Lot T241102. Affected kits include 10-pack and 25-pack models produced between July 23 and September 12, 2025.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Enterix is recalling InSure ONE fecal immunochemical test kits that may give false negative results when used with specific test cards. This could lead to missing early signs of colorectal cancer in users who rely on these tests for screening.
The test may produce false negative results when used with Test Card Lot T241102, meaning it could miss early signs of colorectal cancer. This happens because the test's sensitivity fails under specific conditions with this test card lot.
People who purchased the InSure ONE fecal test kits (10-pack or 25-pack models) with Test Card Lot T241102 between July 23 and September 12, 2025. Those who use these tests for colorectal cancer screening are most at risk.
Check the model number on the kit: 90010 (10-pack), 90025 (25-pack), or 90030 (combo pack). Look for Test Card Lot T241102 on the test card. The kits were produced between July 23 and September 12, 2025.
Look for model numbers 90010, 90025, or 90030 on the kit packaging.
Check the test card for lot number T241102 to confirm if it's affected.
No, the recall does not require stopping use. The tests may give false negatives but are still safe to use with other test card lots.
The recall does not specify a remedy, so you can safely continue using the test with other test card lots if you have the kit.
Check the model number on the kit (90010, 90025, or 90030) and the test card lot number (T241102). Kits produced between July 23 and September 12, 2025 are affected.
We’ve drafted a message you can send Enterix to request your refund or repair — edit it as you like.
Subject: Recall Z-0725-2026 — Enterix Enterix Hello, I own a Enterix that is covered by recall Z-0725-2026 from Enterix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
