Peptic ulcer H. pylori tests recalled for lacking premarket approval or clearance
Get Tested International AB is recalling 12 units of its Peptic Ulcer Test (H. pylori) 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 Peptic Ulcer Test (H. pylori) from Get Tested International AB is being recalled. The product is identified by EAN 616612787309 and SKU 2-B220, 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 12 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
- IntelliVue Multi-Measurement Module X3. Product Number: 867030.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Diagnostic test
- Affected units
- 1,913,441
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 (3)
- Product Number: 867030
- UDI-DI: 00884838082588
- All Serial No.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Philips North America Llc 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.
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