FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: Product: STA Liatest D-Di; REF: 00515;
- Recall number
- Z-0205-2026
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- Product: STA Liatest D-Di; REF: 00515;
- Status
- Open, Classified
- Initiated
- 2025-09-12
- Posted
- 2025-10-16
- Terminated
- not on file
- Reason
- A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
- 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
- 12740 units
- Distribution
- Worldwide distribution- US Nationwide and the country of Canada.
- Lot, serial or model codes
- REF: 00515; UDI-DI: 03607450005158; Lot numbers: 271382, 271411; Expiration 09/30/2025;
- 510(k) numbers
- ["K141144","K162227","K964728"]
- PMA numbers
- not on file
- Product code
- DAP
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28