Reported Sep 3, 2025 · Ongoing
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA…
Diagnostica Stago, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607
Is this the product you have?
- STA-Liquid Anti-Xa 4
- Model/Catalog Number00311US. 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
- Lot codes and dates
- Model/Catalog Number00311US
- UDI-DI03607450011784
- Amount recalled
- 116,600 units (114,600 US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
This product could cause temporary or reversible health problems — stop using it.
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