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
- Candida Test Diagnostic Device
- Model numbers
- EAN: 7340221700888, SKU: B-CAN, 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
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.
Why This Is Dangerous
The hazard stems from distributing a diagnostic device without required premarket approval or clearance. This could affect safety and effectiveness assurances.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The immediate impact is a halt to further use of the specific lots and a dependence on manufacturer guidance for next steps.
Practical Guidance
How to identify if yours is affected
- Check model numbers: EAN 7340221700888 and SKU B-CAN
- Note that Lot/Serial Number: All Lots means all manufactured lots are affected
- Confirm nationwide US distribution as the scope
Where to find product info
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
What timeline to expect
Not specified by manufacturer; typical recall processes may take weeks for refunds or replacements
If the manufacturer is unresponsive
- Escalate to manufacturerA GET TESTED INTERNATIONAL AB for resolution
- File a consumer safety complaint with the FDA if the company is unresponsive
How to prevent similar issues
- Require FDA clearance/approval for diagnostic devices before purchase
- Ask vendors for the premarket approval status
- Verify device type and regulatory status prior to use
Documentation advice
Keep the recall notice, take photos of packaging and model numbers, document dates of purchase and any instructions received
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: GET TESTED INTERNATIONAL AB
- Product: Candida Test
- Model numbers: EAN 7340221700888, SKU B-CAN, All Lots
- Status: ACTIVE, Hazard: Distribution without premarket approval/clearance
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Safety Guide
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