GET TESTED INTERNATIONAL AB recalled 658 parasite tests distributed nationwide in the United States after regulators flagged distribution without premarket approval. The recall, active as of December 2025, targets devices labeled EAN 7340221707153 and SKU A-PARA. Healthcare providers and patients should stop using the device immediately and follow manufacturer 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 Parasite Test is a medical device intended to aid in parasite detection. The recall concerns distribution without premarket clearance, which affects safety and regulatory compliance.
There is a regulatory risk associated with distributing a device without required premarket approval or clearance. The data do not specify medical performance failures.
This recall is not described as part of a broader industry pattern in the provided data.
Consumers should halt use immediately. The recall focuses on regulatory noncompliance rather than an explicit medical failure in the provided information.
Model numbers are on packaging and device labels. The FDA recall page provides official instructions.
Refunds or replacements will be guided by the manufacturer and FDA notice timelines; expect several weeks to process after return approval.
Keep copy of recall notice, model numbers, purchase documentation, and all communications
Brand: GET TESTED INTERNATIONAL AB. Product: Parasite Test. Model identifiers include EAN 7340221707153 and SKU A-PARA. Lot/Serial numbers: All lots. Quantity: 658 units. Distribution: US nationwide. Status: Active recall. Recall date: 2025-11-03. Report date: 2025-12-10.
No injuries or incidents have been reported in the data provided.
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