GET TESTED INTERNATIONAL AB recalled 166 units of its Candida Test distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall 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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Candida Test is a diagnostic tool used to detect Candida infections. It may be intended for consumer or clinical use depending on the product line.
The hazard stems from distributing a diagnostic device without required premarket approval or clearance. This could affect safety and effectiveness assurances.
This recall is not described as part of a broader industry pattern.
The immediate impact is a halt to further use of the specific lots and a dependence on manufacturer guidance for next steps.
Official recall details are on FDA enforcement page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0729-2026
Not specified by manufacturer; typical recall processes may take weeks for refunds or replacements
Keep the recall notice, take photos of packaging and model numbers, document dates of purchase and any instructions received
Model numbers: EAN 7340221700888; SKU B-CAN; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Sold date: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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