GET TESTED INTERNATIONAL AB recalled 754 units of a 2 in 1 Trichomonas / Gardnerella Test distributed nationwide in the United States after regulators found distribution without premarket approval or clearance. The device was distributed without FDA clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer’s recall instructions by contactingGET
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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This product is a diagnostic test intended to detect Trichomonas and Gardnerella infections from a single sample. It is marketed for use by healthcare providers.
The hazard is the distribution of a medical device without FDA premarket approval or clearance, which may affect the product’s safety and effectiveness.
This recall is not described as part of a broader industry pattern in the notice.
No injuries reported to date. The recall affects 754 units and requires immediate stop-use actions by patients and providers.
Labels on packaging and accompanying documentation list the model numbers. UDI-DI is not provided.
Remedies will be issued per manufacturer guidance. Recall processing and replacement or refunds, if available, typically occur within weeks to months.
Keep the recall notice, product labels, model numbers, and all communications with the manufacturer.
Brand: GET TESTED INTERNATIONAL AB. Product: 2 in 1 Trichomonas / Gardnerella Test. Model numbers: EAN 7340221700925; SKU B-TOG; UDI-DI: None; Lot/Serial Number: All Lots. Quantity recalled: 754 units. Distribution: US nationwide. Sold since: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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