Female fertility tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 31 units of its Female Fertility 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 Female Fertility Test from Get Tested International AB is being recalled. The product is identified by EAN 7340221707139 and SKU A-AMH, 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 31 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
- Lotsa Pasta International Food Shop Roasted Garlic Infused Olive Oil, Net Wt. 12 oz. (375ml), packaged in a glass bottle, UPC 736211448415, packed 12 bottles per case
- Manufacturer
- Hale inc
- Category
- Medical Device — Diagnostic test
- Hazard
- unapproved-device
- premarket-clearance
- regulatory
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 (1)
- No codes applied
Distribution
Distributed in 1 state:
- KY
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