BEUDAMED
    9 results · 12ms · Sources: EU EUDAMED, US FDA

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    cobas e801 Immunoassay Analyzer

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·July 14, 2022

    cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code LPS·October 17, 2024

    cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QLT·December 21, 2022

    cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QLT·December 21, 2022

    cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QLT·December 21, 2022

    Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·December 8, 2020

    Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JHS·August 15, 2024

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·December 8, 2020

    Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code GHH·October 3, 2023