GET TESTED INTERNATIONAL AB recalled 4 MPOX Test devices distributed nationwide in the United States after distribution without premarket approval. The recall cites a regulatory violation rather than an injury risk. Healthcare providers and patients should stop using the device immediately and await instructions from the manufacturer.
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 MPOX Test is a diagnostic device intended to detect mpox infections. It is used in clinical or near-patient settings.
The device was distributed without premarket approval or clearance, raising concerns about safety and effectiveness despite no reported injuries.
This recall is not presented as part of a broader industry pattern.
The recall involves a small quantity and no reported injuries, but it underscores potential regulatory gaps in testing devices used for public health.
Look on the device packaging and label for EAN and SKU. See the FDA recall page for Z-0745-2026.
Recall processing and potential refunds or replacements may take 4-6 weeks.
Save recall notice, packaging, model numbers, serial/lot information, and all correspondence with the manufacturer.
Brand: GET TESTED INTERNATIONAL AB. Product: MPOX Test diagnostic device. Model numbers: EAN 7340221708976; SKU A-MPVAR; UDI-DI: None; Lot/Serial Number: All Lots. Sold: Nationwide in the United States.
No injuries or incidents have been reported.
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