Candida test kits, SKU B-CAN, recalled for lacking premarket clearance
Get Tested International AB is recalling 166 units of its Candida Test because the product was distributed without premarket approval or clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a premarket clearance shortfall with no stated product defect, consequence or reported harm.
Plain-English summary
The Candida Test from Get Tested International AB is being recalled. The product is identified by EAN 7340221700888 and SKU B-CAN, and the recall covers all lots.
The reason given in the enforcement record is distribution without premarket approval or clearance.
The record lists a quantity of 166 units, distributed nationwide in the United States. The FDA has classified the action as Class II.
The record describes a regulatory clearance issue rather than a specific product defect, and states no injuries. Customers should follow the firm's instructions.
The recalled product
- Product
- Cholesterol Test
- Manufacturer
- GET TESTED INTERNATIONAL AB
- Category
- Medical Device — Diagnostic test
- Affected units
- 80
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- EAN: 7340221704459
- SKU: DFI-CHT01
- UDI-DI: None
- Lot/Serial Number: All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 92 recalled by GET TESTED INTERNATIONAL AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 92 products in this recall →Related recalls
Same manufacturer · GET TESTED INTERNATIONAL AB
See all →- ModerateGut Microbiome Test Large recalled for distribution without premarket clearance
FDA (Devices) · 2025-12-10
- ModerateThyroid TSH tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateOvulation test kits recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateSerotonin tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- ModerateChlamydia tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
Same hazard · unapproved device
See all →- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien Mon-a-Therm general purpose temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateOne Step 10A In Vitro Diagnostic Test Distributed Without FDA Clearance
FDA (Devices) · 2026-05-13
- ModerateOne Step K in vitro diagnostic test recall for missing FDA clearance
FDA (Devices) · 2026-05-13