5 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Product: STA Liatest D-Di; REF: 00515;
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code DAP·September 12, 2025
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code JPA·March 22, 2023
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code JPA·March 22, 2023
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code JPA·March 22, 2023
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026