GET TESTED INTERNATIONAL AB recalled 45 intestinal worms test units distributed nationwide in the United States. The action follows distribution without premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.
Distribution without premarket approval/clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
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The Intestinal Worms Test is a diagnostic device intended to detect intestinal parasites. It is distributed nationwide in the United States.
The hazard stems from distribution without premarket approval or clearance, a regulatory issue rather than a stated physical hazard.
This recall is not described as part of a broader industry pattern.
The recall affects 45 units and requires immediate cessation of use. Consumers and healthcare providers should follow manufacturer instructions to address refunds or replacements.
Recall details are on the FDA enforcement page linked in the citation and on the manufacturer’s recall notice.
Refund or replacement processing typically 4-6 weeks after verification.
Keep the recall notice, model and serial number information, and all communications with the manufacturer and healthcare providers.
Brand: GET TESTED INTERNATIONAL AB Product: Intestinal Worms Test Model numbers: EAN 616612785978; SKU 2A169; UDI-DI: None; Lot/Serial Number: All Lots Quantity recalled: 45 units Sold in: United States nationwide distribution Recall date: 2025-11-03 Status: ACTIVE
No injuries or incidents have been reported.
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