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Open, Classified

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

FDA Recall Z-0205-2026 · Posted 2025-10-16

Recalling FirmDiagnostica Stago, Inc.
Recall StatusOpen, Classified
Product CodeDAP
Date Initiated2025-09-12
Product Quantity12740 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution- US Nationwide and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162227STA® - Liatest® D-DiDiagnostica Stago · 2016-12-10K964728STA-LIATEST D-DI TEST KITAmerican Bioproducts Co. · 1997-06-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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