InSure ONE Test (Enterix) – False Negative Risk (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
Brand
Enterix, Inc.
Lot Codes / Batch Numbers
1. Model Number: 90010, GTIN:10850093003313, All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 2. Model Number: 90025, GTIN: 20850093003310, All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 3. Model Number: 90030, GTIN: 00850093003279, All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.
Products Sold
1. Model Number: 90010; GTIN:10850093003313; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 2. Model Number: 90025; GTIN: 20850093003310; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 3. Model Number: 90030; GTIN: 00850093003279; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.
Enterix, Inc. is recalling InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. due to InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Recommended Action
Per FDA guidance
Consignees were initially sent an email as notification of the recall on about 09/17/2025, which was followed by a formal recall notification letter on about 09/23/2025. Consignees were instructed to immediately examine inventory and quarantine any affected units, notify customers if affected further distributed, and for those patients that have already been tested using an InSure ONE test kit that has been identified as part of the scope of this recall be retested. Once an inventory count has been received by Enterix, they will provide RMA and courier information so the recalled product can be returned for sorting and destruction.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026