Recall Z-2475-2025— Diagnostica Stago, Inc.

Name: FDA recall Z-2475-2025
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: K111822. Product: STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.. 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

K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.·cleared 2011-10-26

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-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

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.