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FDA (Device enforcement)Recalled 2025-07-21class ii

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, chr

Hazard

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

Details from the source

Reason for recall: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. 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, Quantity: 3,650 units (538 US) Lot/code info: Product Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions.

UPC codes

03607450581041, 03607450581027

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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