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
Enterix, Inc. is recalling InSure ONE Test Strips (25 pack) vials because they do not meet internal testing criteria. This defect may cause false positive results, potentially leading patients to undergo unnecessary follow-up diagnostic procedures like colonoscopies or sigmoidoscopies. The recall affects specific lots distributed in the US and Australia. Read more at govinfonow.com/recall/64106-enterix-insure-one-test-strips-recall-false-positive-risk.
“InSure ONE FIT Test Strip Recall: False Positive Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/64106-enterix-insure-one-test-strips-recall-false-positive-risk. Based on FDA recall #Z-0590-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0590-2021%22&limit=1).
The FDA announced on Oct. 8, 2020, that Enterix, Inc. is recalling InSure ONE Test Strips (25 pack) vials because they may produce false positive results. The agency said the product does not meet internal testing criteria.
How to tell if you have it
Brand: InSure ONE
Product: InSure ONE Test Strips (25 pack)
Model: 12045.01
Lot Numbers: 770G11 and 770G21
The hazard
The FDA said the product does not meet internal testing criteria, which may result in a potential false positive test result. This could lead to patients undergoing unnecessary follow-up diagnostic procedures, such as colonoscopy or sigmoidoscopy.
Context
GovInfoNow's records show Enterix, Inc. has one other recall on record since Sept. 17, 2025. Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), Vivoo Test Strips Recall (Nov. 22, 2025), and Exploro Fertility Test Recall (Nov. 22, 2025).
How to tell if you have this one
Check your InSure ONE Test Strips (25 pack) vials for Model number 12045.01. Verify the lot numbers on the packaging; the recalled lots are 770G11 and 770G21. These products were distributed nationwide in the US and in Australia.
Brand
InSure ONE
Category
Medical device
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Australia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0590-2021 (October 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0590-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.