Health & Personal Care
HIGH
FDA DEVICE
Enterix InSure ONE FIT Recall Affects 201,426 Tests Over False Negatives (2025)
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.
Enterix
InSure ONE