BEUDAMED
    166 results · 59ms · Sources: EU EUDAMED, US FDA

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    epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JGS·July 7, 2025

    Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JHM·February 3, 2021

    Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JHX·March 31, 2025

    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·September 24, 2024

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code PDJ·February 9, 2022

    Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code NDW·February 9, 2022

    Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CJY·February 9, 2022

    Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code LCP·February 9, 2022

    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021

    Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JGS·May 13, 2021

    Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021

    epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·October 19, 2023

    Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc·Product code MOI·July 6, 2021

    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 2022

    Atellica CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test Code: HDLC Siemens Material Number (SMN): 11537213

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JFM·July 10, 2023

    Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JFM·July 10, 2023

    RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JIX·October 26, 2023

    RAPIDPOINT 500 Blood Gas System

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code JGS·September 26, 2023

    Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CFN·December 15, 2023

    Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·May 7, 2020