Recall Z-1585-2026 · DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Diagnostica Stago, Inc.
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel.
| Date | Mar 19, 2026 (initiated Feb 5, 2026) |
| Status | Open, Classified |
| Reason | After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. |
| Root cause | Process change control |
| Action | On February 5, 2026 QUALITY ALERT letters were emailed to customers. Actions required: 1. As the intended purpose of the kit is to exclude PE and DVT, and its sensitivity and negative predictive value remain unchanged, it is appropriate to continue utilizing the reagents. 2. Please complete, sign and return the attached Acknowledgement Form by email, as directed on the form. In the event that a patient experiences an adverse event with any medical device, you may report it to FDA; see the guidance document Medical Device Reporting for User Facilities, which is available on the FDA.gov websi |
| Quantity | 34000 units (28446 US, 5554 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162227 | STA® - Liatest® D-Di Diagnostica Stago, Dec 10, 2016 |