FDA Medical devices recall ·
STA Liatest D-Di recall
- Recall number
- Z-0205-2026
- Date
- (initiated September 12, 2025)
- Company / brand
- Diagnostica Stago, Inc.
5 Century Dr, Parsippany, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12740 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Product: STA Liatest D-Di; REF: 00515;
Why was it recalled?
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
Distribution
Worldwide distribution- US Nationwide and the country of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0205-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.