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584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. DiaSorin Ine. US, FSN-WS1000069, LIAISON® 1-84 PTH Assay

    DiaSorin has confirmed that the LIAISON® 1-84 PTH Assay {REF 310630) lot numbers 134909, 134909A and 1349098, may produce falsely ...

    Waarschuwing | 27-11-2020

  2. Gentian AS CC-167 - Gentian Cystatin C Calibrator and Calibrator Kit

    The identified lots of calibrators have shown to measure incorrect high values over time compared to the assigned values when ...

    Waarschuwing | 02-09-2020

  3. Sanquin Reagents FSN 103549 - Screening panel

    Bij kwaliteitsonderzoek is gebleken dat cel van deze panels (donorcode 384549) op het bijbehorende antigram ten onrechte staat ...

    Waarschuwing | 26-10-2017

  4. Field Safety Notice: Analyzer versions 1.0.0, 1.1.0 and 1.4.0.0.0.1 of the FluoroType HSV VER 1.0

    In the FluoroCycler Report and in the result window of the Fluoro-Software IVD (tab 'Results HSV") Analyzer versions 1.0.0, 1.1.0 ...

    Waarschuwing | 02-06-2017

  5. Field Safety Notice: Siemens - Digital Linear Accelerators ARTISTE™, ONCOR™ and PRIMUS™

    It has come to our attention that incorrect values for the rotational collimator position have been displayed. This can happen, ...

    Waarschuwing | 08-03-2017

  6. Field Safety Notice: Cepheid - Xpert CT/NG- test

    Wij willen er u op attenderen dat bij sommige van onze gebruikers er zich een hoger aantal "invalid" resultaten hebben ...

    Waarschuwing | 08-03-2017

  7. Greiner Bio-One R002_20 - MiniCollect 9NC Coagulation Tube

    As a result of our post market clinical follow up process and based on internal testing, it was identified that MiniCollect® 9NC ...

    Waarschuwing | 04-03-2020

  8. DiaMed GmbH, FSCA 003-24, ID-DiaCell I-II-III, ID-DiaCell I-II-III Asia, LISS/Coombs, Coombs Anti-IgG

    We have been able to confirm an increased level of complaints and adverse events related to weak non-specific reactions when ...

    Waarschuwing | 25-06-2024

  9. Abbott Diagnostics Technologies AS, FCA-00000294, Afinion 2

    This letter is to inform you that Abbott has identified an issue related to cracks developing in an internal component (pump ...

    Waarschuwing | 06-06-2024

  10. Abbott Molecular, Inc., FA-AM-MAR2024-298, Alinity m System

    The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present ...

    Waarschuwing | 25-03-2024

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