GET TESTED INTERNATIONAL AB recalled 13 iodine test devices distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s 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 product is an iodine test device used in healthcare settings. It is distributed nationwide in the United States by GET TESTED INTERNATIONAL AB.
The risk arises from distribution without premarket approval or clearance, which may indicate unknown safety and effectiveness concerns for patients.
This recall is not described as part of a broader industry pattern in the supplied information.
Consumers and clinicians must halt use and follow recall instructions to avoid potential unverified risks from an unapproved device.
Refer to the FDA recall page for official instructions and contact information.
Refund or replacement processing timelines are determined by the manufacturer after recall validation; typical timelines may vary.
Keep copy of recall notices, product packaging, photos of labeling, and all correspondence with manufacturer
Model numbers: EAN 616612785572; SKU 1JO; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Price: Unknown.
No injuries or incidents have been reported.
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