12 results
·
37ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code PPM·May 21, 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.
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code KFF·July 21, 2025
Product: STA Liatest D-Di; REF: 00515;
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code DAP·September 12, 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.
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code KQJ·July 21, 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.
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code JPA·July 21, 2025
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
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
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA - Liatest Free Protein S kits are intended for use on STA-R and STA Compact for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code GGP·February 4, 2026
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code LCO·December 15, 2025
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
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.
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code KFF·July 21, 2025