BEUDAMED
    41 results · 49ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJT·January 28, 2013

    PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGW·April 13, 2005

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. 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
    Terminated ·Diagnostica Stago, Inc.·Product code KFF·July 18, 2014

    STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Distributed in the USA by : Diagnostica Stago, Inc, Five Century Drive, Parsippany, NJ 07054, Lot 02019***.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code JOX·December 20, 2002

    STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGP·May 8, 2007

    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

    FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code DAP·December 4, 2002

    STA SYSTEM CONROL N + P (ref. 00678)

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGN·November 18, 2019

    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 Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code JPA·June 15, 2012

    Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·October 25, 2017

    Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GJS·July 24, 2018

    STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGP·March 4, 2020

    STA UNICALIBRATOR (ref. 00675)

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GIZ·November 18, 2019

    STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GKP·July 30, 2007

    STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code GGP·March 13, 2007

    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