Diagnostica Stago, Inc. recalls STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop ana…

Recall date

July 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2473-2025

FDA classification

Class II

Brand / firm

Diagnostica Stago, Inc.

Sold / distributed

Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran,…

Why it was recalled

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.