Stago STA-Liquid Anti-Xa 4 kits may contaminate heparin tests
Stago recalls STA-Liquid Anti-Xa 4 kits (model 00311US) due to potential contamination with fibrinogen reagents in heparin tests. Affected users should contact Stago for details.
Lower-risk recall
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Contact the company
What happened, in plain English
Stago recalls its STA-Liquid Anti-Xa 4 kits (model 00311US) because they might mix with fibrinogen reagents used in heparin tests. This could lead to inaccurate test results if the kits are used with certain analyzers. Read more at govinfonow.com/recall/51764-stago-sta-liquid-anti-xa-4-kits-may-contaminate-heparin.
Source Summary by GovInfoNow · govinfonow.com/recall/51764-stago-sta-liquid-anti-xa-4-kits-may-contaminate-heparin · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2474-2025
Cite this page
“Stago STA-Liquid Anti-Xa 4 kits may contaminate heparin tests.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51764-stago-sta-liquid-anti-xa-4-kits-may-contaminate-heparin. Based on FDA recall #Z-2474-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2474-2025%22&limit=1).
Why it’s dangerous
The kits could mix with fibrinogen reagents used in unfractionated heparin (UFH) and low molecular weight heparin (LMWH) tests. This contamination might cause inaccurate test results, but it does not cause direct harm to users.
Who’s affected
Healthcare professionals using Stago's STA-Liquid Anti-Xa 4 kits for heparin level testing with specific analyzers are most at risk. Patients receiving these tests may be affected if the kits are used incorrectly.
How to tell if you have this one
Check for the model number 00311US on the kit packaging. The kits are intended for use with Stago STA-R, STA Compact, or STA Satellite analyzers for heparin level testing.
- Brand
Stago- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2473-2025 | 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.; Product Code: All references. UDI-DI: 03607450581041, 03607450581027. All software versions. | 3,650 units (538 US) |
| Z-2474-2025 | STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. 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.; Model/Catalog Number: 00311US. UDI-DI: 03607450011784. | 116,600 units (114,600 US) |
| Z-2475-2025 | 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.; Model/Catalog Number: 00322US. UDI-DI: 03607450011791 | 126,200 units (125,900 US) |
| Z-2476-2025 | STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families for the quantitative determination of fibrinogen levels in human citrated plasma by the clotting method of Clauss.; Model/Catalog Number: 00674. UDI-DI: 13607450006749 | 829,800 units (245,200 US) |
What to do — step by step
Contact Stago
Reach out to Stago directly for specific instructions on how to handle the recalled kits.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 21 states.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Louisiana, Maine, Maryland, Minnesota, Missouri, Montana, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Dakota, Vermont, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2474-2025 (July 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2474-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.