STA Satellite (Diagnostica Stago) – Contamination Risk (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
Product Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions.
Products Sold
Product Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions.
Diagnostica Stago, Inc. is recalling STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully au due to Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Recommended Action
Per FDA guidance
Diagnostica Stago notified consignees on about 07/21/2025 via emailed letter titled URGENT: MEDICAL DEVICE RECALL (CORRECTION). Consignees were instructed to temporarily systematically run a quality control just before a batch of UFH or LMWH, if you run STA-LIQUID ANTI-Xa in UFH and LMWH applications on your STA SATELLITE analyzer. This request is being asked while Stago works to develop a permanent solution for the analyzer. Consignees were also requested to complete and return the Acknowledgement Form and to notify customers if affected units were transferred or further distributed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026