FDAClass IIOctober 22, 2025

STA Liatest D-Di recall

Product: STA Liatest D-Di; REF: 00515;

Why was STA Liatest D-Di recalled?

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

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?

REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;

Product
Product: STA Liatest D-Di; REF: 00515;
Recalling firm
Diagnostica Stago, Inc.
Quantity
12740 units
Distribution
Worldwide distribution- US Nationwide and the country of Canada.
Recall date
October 22, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls