Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GET TESTED INTERNATIONAL AB
- Product type
- Diagnostic Test Kit
- Model numbers
- EAN: 7340221700925, SKU: B-TOG, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Distribution without premarket approval/clearance.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
The hazard is the distribution of a medical device without FDA premarket approval or clearance, which may affect the product’s safety and effectiveness.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
No injuries reported to date. The recall affects 754 units and requires immediate stop-use actions by patients and providers.
Practical Guidance
How to identify if yours is affected
- 1. Locate the product label for EAN 7340221700925 or SKU B-TOG.
- 2. Confirm the lot/serial number states All Lots.
- 3. Verify the product is from GET TESTED INTERNATIONAL AB.
Where to find product info
Labels on packaging and accompanying documentation list the model numbers. UDI-DI is not provided.
What timeline to expect
Remedies will be issued per manufacturer guidance. Recall processing and replacement or refunds, if available, typically occur within weeks to months.
If the manufacturer is unresponsive
- File a report with the FDA if the manufacturer is unresponsive.
- Consult your healthcare provider for alternatives and guidance.
How to prevent similar issues
- Check FDA recall databases before purchasing diagnostic tests.
- Verify premarket approval or clearance status before use.
- Purchase only from reputable suppliers with recall history reviewed.
Documentation advice
Keep the recall notice, product labels, model numbers, and all communications with the manufacturer.
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product: 2 in 1 Trichomonas / Gardnerella Test
- Brand: GET TESTED INTERNATIONAL AB
- Model numbers: EAN 7340221700925; SKU B-TOG; Lot: All Lots
- Distribution: US nationwide
- Hazard: Distribution without premarket approval/clearance
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Safety Guide
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