CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report

STA Satellite recalled by Diagnostica Stago

Diagnostica Stago is recalling STA Satellite, distributed nationwide in the US. The recall was initiated on 21 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions.

Quantity recalled3,650 units (538 US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2473-2025
FDA event ID: 97287
Recalling firm: Diagnostica Stago, Parsippany, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 21 Jul 2025
FDA classified: 29 Aug 2025
Reported: 3 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

21 Jul 2025	Recall initiated by company
29 Aug 2025	Classified by FDA	+39 days
3 Sep 2025	Published in enforcement report	+5 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was 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, 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.

Nationwide Alabama Arizona California Colorado Florida Georgia Louisiana Maryland Maine Minnesota Missouri Montana North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Dakota Vermont

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 97287

This product is part of a recall event; the main page for the event is STA-Liquid Anti-Xa recalled by Diagnostica Stago.

Reported	Class	Recall	Company	Reason	Where
3 Sep 2025	CLASS II	STA-Liquid Anti-Xa recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
3 Sep 2025	CLASS II	STA-Liquid Anti-Xa recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
3 Sep 2025	CLASS II	STA - Fibrinogen recalled by Diagnostica Stago	Diagnostica Stago	Other	Nationwide

More recalls from Diagnostica Stago

All 27

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	STA Staclot Protein recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
25 Mar 2026Device	CLASS II	STA Liatest D-Di recalled by Diagnostica Stago	Diagnostica Stago	Potency & Assay	Nationwide
11 Mar 2026Device	CLASS II	STA Liatest Free Protein recalled by Diagnostica Stago	Diagnostica Stago	Device Malfunction	Nationwide
21 Jan 2026Device	CLASS II	Asserachrom HPIA recalled by Diagnostica Stago	Diagnostica Stago	Device Malfunction	Nationwide
22 Oct 2025Device	CLASS II	STA Liatest D-Di recalled by Diagnostica Stago	Diagnostica Stago	Other	Nationwide

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