Diagnostica Stago, Inc. has issued a voluntary recall for approximately 1,076,250 units of its STA Satellite laboratory analyzers and associated testing reagents, including STA-Liquid Anti-Xa and STA-Fibrinogen 5 kits. The recall was initiated because the STA-Liquid Anti-Xa testing reagent can become contaminated by Fibrinogen reagents during certain automated testing procedures. These products are used in clinical laboratories to measure the levels of blood-thinning medications, such as heparin, in a patient's plasma.
The contamination of these reagents can lead to inaccurate laboratory test results for patients receiving heparin therapy. This could result in healthcare providers prescribing incorrect doses of medication, potentially leading to serious health risks like excessive internal bleeding or the formation of dangerous blood clots.
Corrective Action
Recall Number: Z-2473-2025. Automated benchtop analyzer for clotting, chromogenic, and immunologic assays.
Recall Number: Z-2474-2025. Used for quantitative determination of UFH and LMWH heparin levels.
Recall Number: Z-2475-2025. Used for quantitative determination of UFH and LMWH heparin levels.
Recall Number: Z-2476-2025. Used for quantitative determination of fibrinogen levels in human citrated plasma.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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