Enterix recalled 201,426 InSure ONE Fecal Immunochemical Test kits after a sensitivity failure linked to Test Card Lot TT241102. The issue may cause false negative results. Healthcare providers and patients should stop using the affected kits and follow the manufacturer’s recall instructions.
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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InSure ONE is a fecal immunochemical test used to screen for occult blood in stool. It qualitatively detects human hemoglobin in fecal samples.
The product failed sensitivity testing with Test Card Lot TT241102, which may yield false negative results and delay detection of conditions.
This recall is not described as part of a broader industry pattern.
Consumers could receive falsely normal results, potentially delaying diagnosis and treatment.
Official recall notices and guidance are issued by Enterix via email and FDA recall page. The listed GTINs are 10850093003313 (90010), 20850093003310 (90025), 00850093003279 (90030).
Refunds or replacements, if offered, typically follow the company’s recall process. Consumers should expect updates via recall emails.
Keep the purchase receipt, packaging, recall notices, GTINs, model numbers, and any correspondence with Enterix or healthcare providers.
Model 90010 Insure ONE POL Patient Kit 10 pack. GTIN 10850093003313. All lots produced 2025-07-23 to 2025-09-12 with Test Card Lot TT241102. Model 90025 Insure ONE POL Patient Kit 25 pack. GTIN 20850093003310. All lots produced 2025-07-23 to 2025-09-12 with Test Card Lot TT241102. Model 90030 InSure ONE POL Combo Pack. GTIN 00850093003279. All lots produced 2025-07-23 to 2025-09-12 with Test Card Lot TT241102. Distribution: Worldwide. US states include CA, FL, GA, IL, IN, KY, MA, NV, NJ, NY, NC, OH, PA, TX, WA, WV; Philippines included.
No injuries or incidents have been reported in the recall notice.
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