Enterix recalled 201,426 InSure ONE fecal immunochemical test kits on September 17, 2025. The kits may produce false negative results due to failed sensitivity testing with Test Card Lot T241102. The recall affects units distributed worldwide, including multiple states in the U.S.
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Enterix, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The recalled models include Insure ONE POL Patient Kit - 10 pack (Model Number: 90010), Insure ONE POL Patient Kit - 25 pack (Model Number: 90025), and Insure ONE POL Combo Pack (Model Number: 90030). These kits were distributed from July 23, 2025, to September 12, 2025.
The InSure ONE test kits may yield false negative results, potentially leading to undetected health issues. This issue arises from a failure in sensitivity testing with a specific test card lot.
There are no reported injuries or incidents associated with this recall. The potential risk lies in the failure to detect conditions that could be serious.
Stop using the recalled test kits immediately. Follow the recall instructions provided by Enterix, Inc. Contact your healthcare provider for guidance.
For more information, contact Enterix, Inc. at the email provided in the recall notification. Visit the FDA website for further details.
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