GET TESTED INTERNATIONAL AB's Mycotoxin Panel Test was recalled after two units were distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions or contact a healthcare provider for guidance.
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 Mycotoxin Panel Test is a diagnostic test used to assess mycotoxin exposure. It is distributed by GET TESTED INTERNATIONAL AB in the United States.
The hazard relates to distribution of a medical device without FDA premarket approval or clearance, which can mean the product may not have been evaluated for safety or effectiveness.
This recall is not indicated as part of a broader industry pattern in the data provided.
With only two units affected and nationwide distribution noted, consumer impact is limited but regulatory noncompliance poses safety and trust concerns for users.
FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0765-2026
Not specified in the recall notice.
Keep the recall letter, packaging, model numbers, and any correspondence with the manufacturer for records.
Brand: GET TESTED INTERNATIONAL AB Product: Mycotoxin Panel Test Model numbers: EAN 7340221709300, SKU UMT UDI-DI: None Lot/Serial Number: All Lots Distribution: US Nationwide distribution Sold at: Unknown When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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