Recall
FDAHealthJuly 21, 2025

Diagnostica Stago, Inc. — STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting,

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
July 21, 2025

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, Israel, Jordan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Oman, Paraguay, Peru, Republique Tcheque, Romania, Saudi Arabia, Serbia, South Africa, Switzerland, Taiwan, Thailand, Tunisia, Turquie, United Arab Emirates, Uruguay, Vietnam.

What's affected?

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.
Lot code
Product Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions.

Additional details

Product Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3,650 units (538 US).

View original FDA notice →

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