Gut Microbiome Test Mega recalled for distribution without premarket clearance
Get Tested International AB is recalling 2 units of its Gut Microbiome Test Mega 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 Gut Microbiome Test Mega from Get Tested International AB is being recalled. The product is identified by EAN 616612786944 and SKU 2A713BWG-A500, 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 2 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
- SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC)
- Brand
- SALINE ENEMA
- Manufacturer
- Blossom Pharmaceuticals
- Category
- Medical Device — Diagnostic test
- Affected units
- 18,912
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 (7)
- Lot #: A022310
- Exp. Date 2/26
- A022335
- Exp. Date 10/26
- A022406
- Exp Date 12/27 & A022505
- Exp Date 12/27
UPCs (1)
- 0616784471914
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Blossom Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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