Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. William A. Cook Australia Pty Ltd, 2023FA0004/QCR-2023-04, Zenith Branch Endovascular Graft and Bifurcated Iliac Sidebranch Endovascular Graft

    William A. Cook Australië heeft meldingen ontvangen over het feit dat de kathetertip, een onderdeel van het Zenith® Branch ...

    Waarschuwing | 07-04-2023

  2. Inpeco SA, FSCA - FLX - 202303 - 01, FlexLab

    Core Diagnostics has received the attached letter from Inpeco, the manufacturer of FlexLab. The firmware of the modules listed ...

    Waarschuwing | 03-04-2023

  3. Helena Biosciences Europe, FSN-NC661, Collagen

    This lot of Collagen has demonstrated poor aggregation response at very low doses of 1.25ug/mL

    Waarschuwing | 23-03-2023

  4. HYPHEN BioMed, FSN-FSCA29, BIOPHEN TM Protein C LRT

    The R2 of the products listed above contains Cesium Chlodride. Following information from our supplier, this substance has ...

    Waarschuwing | 16-03-2023

  5. Thermo Fisher Scientific, FSN-2023-001, Thermo Scientific Oxoid MacConkey Agar wout Salt

    Continued use of this lot may result in delay to patient treatment

    Waarschuwing | 16-03-2023

  6. Inpeco SA, FSCA - AP2 - 202303 - 03, Aptio Automation

    The firmware of the modules listed above has the potential to mis-associate sample IDs leading to incorrect results or delayed ...

    Waarschuwing | 14-03-2023

  7. Inpeco SA, FSCA - ACP - 202303 - 02, Accelerator a3600

    The firmware of the modules listed above has the potential to mis-associate sample IDs leading to incorrect results or delayed ...

    Waarschuwing | 14-03-2023

  8. Inpeco SA, FSCA - FLX - 202303 - 01, FlexLab

    The firmware of the modules listed above has the potential to mis-associate sample IDs leading to incorrect results or delayed ...

    Waarschuwing | 14-03-2023

  9. Helena Biosciences Europe, FSN-NC643, ProtoFluor-Z Reagent Kit

    Mislabeled bottles of the PFZ reagent kit, which prevents calibration of the PFZ instrument. The calibrators of this lot will not ...

    Waarschuwing | 09-03-2023

  10. Siemens Healthcare Diagnostics, AIMC 23-03, Atellica, ADVIA Centaur

    Negative Bias when Customers use Whole Blood ... Calibration for Serum Samples

    Waarschuwing | 15-02-2023