Home / Recalls / Diagnostica Stago, Inc. / Z-2473-2025

Z-2473-2025 Class II Ongoing

Recalled by Diagnostica Stago, Inc. — Parsippany, NJ

FDA device recall Z-2473-2025 was initiated by Diagnostica Stago, Inc. on July 21, 2025 and is designated Class II. Reason for recall: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. The recall status is ongoing. Affected quantity: 3,650 units (538 US).

Recall Details

Product Type
Devices
Report Date
September 3, 2025
Initiation Date
July 21, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,650 units (538 US)

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.

Distribution Pattern

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.

Code Information

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

Other recalls by Diagnostica Stago, Inc.

  • Z-1585-2026 Class II — Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Numb (February 5, 2026)
  • Z-1491-2026 Class II — Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S (February 4, 2026)
  • Z-1084-2026 Class II — Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is (December 15, 2025)
  • Z-0205-2026 Class II — Product: STA Liatest D-Di; REF: 00515; (September 12, 2025)
  • Z-2476-2025 Class II — STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit (July 21, 2025)
  • Z-2474-2025 Class II — STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa (July 21, 2025)
  • Z-2475-2025 Class II — STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-X (July 21, 2025)
  • Z-1993-2025 Class II — STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffe (May 21, 2025)
  • Z-1576-2023 Class II — STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 586 (March 22, 2023)
  • Z-1575-2023 Class II — STA R Max fully automatic clinical instrument designed to perform tests on human (March 22, 2023)

FDA data resources