Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitr

FDA device recall Z-1585-2026 · posted 2026-03-19 · Open, Classified

Recall details

Recalling firm

Diagnostica Stago, Inc.

Reason for recall

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

Action taken

On February 5, 2026 QUALITY ALERT letters were emailed to customers. Actions required: 1. As the intended purpose of the kit is to exclude PE and DVT, and its sensitivity and negative predictive value remain unchanged, it is appropriate to continue utilizing the reagents. 2. Please complete, sign and return the attached Acknowledgement Form by email, as directed on the form. In the event that a patient experiences an adverse event with any medical device, you may report it to FDA; see the guidance document Medical Device Reporting for User Facilities, which is available on the FDA.gov website, for instructions. For additional information, please contact Stago s 24/7 Hotline at 1-800-725-0607.

Root cause

Process change control

Status

Open, Classified

Product code

DAP

Quantity affected

34000 units (28446 US, 5554 OUS)

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.

Date initiated

2026-02-05

Date posted

2026-03-19

Location

Parsippany, NJ

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