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U.S. Department of Health and Human Services

Class 2 Device Recall InSure ONE test

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 Class 2 Device Recall InSure ONE testsee related information
Date Initiated by FirmSeptember 17, 2025
Date PostedNovember 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0725-2026
Recall Event ID 97802
510(K)NumberK170548 
Product Classification Reagent, occult blood - Product Code KHE
ProductInSure 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.
Code Information 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.
Recalling Firm/
Manufacturer		 Enterix, Inc.
236 Fernwood Ave
Edison NJ 08837-3839
For Additional Information ContactErica Franco
732-429-1899
Manufacturer Reason
for Recall		InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
FDA Determined
Cause 2		Under Investigation by firm
ActionConsignees 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.
Quantity in Commerce201,426 test kits
DistributionWorldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KHE
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