Enterix recalls 25-pack InSure ONE Test Strips (Model : 120045.01) due to potential false positives causing unnecessary colonoscopies. Affected lots: 770G11 and 770G21.
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 is recalling 25-pack InSure ONE Test Strips (FIT) because they might give false positive results, leading to unnecessary colonoscopies. This could cause unnecessary medical procedures for people who don't need them.
The test strips might show a positive result for blood when there isn't any, causing unnecessary follow-up procedures like colonoscopies. This could lead to extra medical tests and potential discomfort or risks from those procedures.
People who use fecal immunochemical test (FIT) kits for colon cancer screening may be affected. Those who have recently used the recalled model (12045.01) or lots 770G11/770G21 are most at risk.
Check for the model number 12045.01 on the vial packaging. Look for lot numbers 770G11 or 770G21 on the label.
Verify the model number (12045.01) and lot numbers (770G11 or 770G21) on the vial packaging.
The test strips might give false positive results for blood, leading to unnecessary colonoscopies or sigmoidoscopies.
Check the model number and lot numbers on the packaging. If they match the recalled model (12045.01) and lots (770G11 or 770G21), contact Enterix for guidance.
The recall is for potential false positives, not immediate safety risks. You can continue using them if you check the model and lot numbers first.
We’ve drafted a message you can send Enterix to request your refund or repair — edit it as you like.
Subject: Recall Z-0590-2021 — Enterix Enterix Hello, I own a Enterix that is covered by recall Z-0590-2021 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.
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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.
