Class 2 Device Recall STA Liatest DDi

• Date Initiated by Firm: September 12, 2025
• Date Posted: October 16, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0205-2026
• Recall Event ID: 97596
• 510(K)Number: K141144 K162227 K964728
• Product Classification: Fibrinogen and fibrin split products, antigen, antiserum, control - Product Code DAP
• Product: Product: STA Liatest D-Di; REF: 00515
• Code Information: REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025
• FEI Number: 2245451
• Recalling Firm/ Manufacturer: Diagnostica Stago, Inc.; 5 Century Dr; Parsippany NJ 07054-4607
• For Additional Information Contact: Technical Hotline; 800-7250607
• Manufacturer Reason for Recall: A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DAP; 510(K)s with Product Code = DAP