PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: September 3, 2025 Initiated: July 21, 2025 #Z-2473-2025

Product Description

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 for Recall

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

Details

Recalling Firm
Diagnostica Stago, Inc.
Units Affected
3,650 units (538 US)
Distribution
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.
Location
Parsippany, NJ

Frequently Asked Questions

What product 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.. Recalled by Diagnostica Stago, Inc.. Units affected: 3,650 units (538 US).
Why was this product recalled?
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 3, 2025. Severity: Moderate. Recall number: Z-2473-2025.