BEUDAMED
    5 results · 47ms · Sources: EU EUDAMED, US FDA

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    Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code MMI·November 18, 2024

    Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code OZN·December 5, 2025

    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