FDA Device recall Z-2473-2025
STA Satellite
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of STA Satellite by Diagnostica Stago, citing potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2473-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-21 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
Product
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
Reason
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Identifiers
| code_info | Product Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Diagnostica Stago
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074
FDA Device · Class II · 2026-09-09 · Diagnostica Stago - Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic
FDA Device · Class II · 2026-03-25 · Diagnostica Stago - Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The…
FDA Device · Class II · 2026-03-11 · Diagnostica Stago - Asserachrom HPIA. Model/Catalog Number: 00615
FDA Device · Class II · 2026-01-21 · Diagnostica Stago - Product: STA Liatest D-Di
FDA Device · Class II · 2025-10-22 · Diagnostica Stago
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2473-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.