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U.S. Department of Health and Human Services

Class 2 Device Recall GetTested

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 Class 2 Device Recall GetTestedsee related information
Date Initiated by FirmNovember 03, 2025
Date PostedDecember 01, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0787-2026
Recall Event ID 97896
Product Classification Calprotectin, fecal - Product Code NXO
ProductLeaky Gut Test
Code Information EAN: 616612785923; SKU: A500; UDI-DI: None; Lot/Serial Number: All Lots;
Recalling Firm/
Manufacturer		 GET TESTED INTERNATIONAL AB
59334 Vastervik
Lysingsvagen 18
Vastervik Sweden
Manufacturer Reason
for Recall		Distribution without premarket approval/clearance.
FDA Determined
Cause 2		No Marketing Application
ActionOn November 3, 2025, MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: If you still have an unused test, it should not be used. You should render the kit unusable and discard the defaced components in accordance with ordinary household disposal practices and applicable local regulations. If your kit has already been used: You do not need to return used components. Please do not base medical decisions solely on that prior result and do not use any remaining units. If you have questions about your results or your health, consult your healthcare provider, who may recommend retesting using an FDA-authorized test that is appropriate for your situation. You may still contact us through the form for support or goodwill assistance regarding your order. Forwarding requirement for further distribution: If you further distributed the affected product(s) to other locations or customers, please immediately forward this notice to all downstream recipients and ensure they stop use/stop distribution, quarantine, and follow the disposition instructions.
Quantity in Commerce31 units
DistributionUS Nationwide distribution.
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.
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