DHEA tests recalled for distribution without premarket approval or clearance
Get Tested International AB is recalling 17 units of its DHEA Test because the product was distributed without premarket approval or clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 DHEA Test from Get Tested International AB is being recalled. The product is identified by EAN 616612786418 and SKU O320, 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 17 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 Patient Monitor MX100. Product Number: 867033.
- 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: 867033
- UDI-DI: 00884838082595
- 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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