Diagnostica Stago, Inc. STA-Liquid Anti-Xa 8. Model/ recall: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2475-2025
- Published
- September 3, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Diagnostica Stago, Inc.
- Product type
- Medical devices
- Units affected
- 126,200 units (125,900 US)
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Model/Catalog Number: 00322US. UDI-DI: 03607450011791
- UPC codes
- 03607450011791
Products covered by this recall
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.
Check your product
The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 03607450011791
Model or item number
On the rating label, the box or the instruction sheet.
- 00322US. UDI-DI
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Diagnostica Stago, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
Company contact: Diagnostica Stago, Inc. — 5 Century Dr, Parsippany, NJ, 07054-4607
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Diagnostica Stago, Inc. medical devices recalled?
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 03607450011791; model number 00322US. UDI-DI. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
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