FDAClass IIDecember 10, 2025

D-Dimer Test recall

D-Dimer Test

Why was D-Dimer Test recalled?

Distribution without premarket approval/clearance.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

EAN: 7340221700475; SKU: A-CDM; UDI-DI: None; Lot/Serial Number: All Lots;

Product
D-Dimer Test
Recalling firm
GET TESTED INTERNATIONAL AB
Quantity
1218 units
Distribution
US Nationwide distribution.
Recall date
December 10, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls