Z-0205-2026Class II

Product: STA Liatest D-Di; REF: 00515

Name: Z-0205-2026 Product: STA Liatest D-Di; REF: 00515
Creator: Diagnostica Stago, Inc.
Published: 2025-09-12
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2025-09-12 / Open, Classified

FDA source

Diagnostica Stago, Inc. began a recall of Product: STA Liatest D-Di; REF: 00515 on 2025-09-12. FDA classified it as Class II and gives the reason as "A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0205-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-12
Posted: 2025-10-16
Recalling firm: Diagnostica Stago, Inc.
Product: Product: STA Liatest D-Di; REF: 00515;
Product code: DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Reason for recall: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
FDA root cause: Under Investigation by firm
Action: On September 12, 2025 URGENT: MEDICAL DEVICE RECALL (REMOVAL) letters were emailed to customers. Actions for customers: Discontinue use of affected lots and dispose of them in accordance with your local regulations. Complete and return response form. For additional information, please contact Stago's 24/7 Hotline at 1-800-725-0607.
Quantity in commerce: 12740 units
Distribution: Worldwide distribution- US Nationwide and the country of Canada.
Product codes and lots: REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0205-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0205-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16

Product code DAP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)