STA-Liquid Anti-Xa Diagnostic Test Kit Recalled for Potential Contamination
Diagnostica Stago is recalling STA-Liquid Anti-Xa diagnostic test kits due to potential contamination from fibrinogen reagents. The kits measure anticoagulant medication levels in clinical laboratories nationwide and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a diagnostic test kit with potential contamination. No illnesses or injuries have been reported. As a risk-of-harm product where injury has not yet been reported, this meets the High severity threshold.
Plain-English summary
Diagnostica Stago, Inc. is recalling STA-Liquid Anti-Xa 4 test kits (Model/Catalog Number 00311US) due to potential contamination from fibrinogen reagents. Approximately 114,600 units have been distributed in the United States, with 116,600 units recalled worldwide.
The STA-Liquid Anti-Xa kits are diagnostic devices used to measure blood anticoagulant levels in clinical laboratories. They work with STA-R, STA Compact, and STA Satellite analyzers to determine plasma levels of unfractionated heparin (UFH) and low molecular weight heparin (LMWH). Accurate measurement of these medication levels is essential for proper anticoagulation therapy.
Healthcare facilities using STA-Liquid Anti-Xa kits should discontinue use of affected products and contact Diagnostica Stago, Inc. for instructions on product replacement or return.
The recalled product
- Product
- 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
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- contamination
- measurement-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model/Catalog Number: 00311US. UDI-DI: 03607450011784.
Distribution
Distributed nationwide across the United States.
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