Recall Z-2473-2025— Diagnostica Stago, Inc.

Name: FDA recall Z-2473-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-21

Class II · Ongoing

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2025-07-21. It names one FDA 510(k) clearance: K082248. 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.. Reason: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications..

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-07-21
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K082248 — STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZERDiagnostica Stago, Inc.·cleared 2008-12-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.