Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. BD, BDB-23-4854, BD® CD11b APC

    BD heeft aan de hand van acht (8) onderzoeken naar klachten van klanten bevestigd dat het bovenstaande lot van BD™ CD11b APC, CE ...

    Waarschuwing | 15-12-2023

  2. Cepheid, 23FAR014, Xpert Xpress CoV-2/Flu/RSV plus

    Bepaalde laboratoria die de Xpert® Xpress CoV-2/Flu/RSV plus-test en de beoogde monstertypen gebruiken, hebben een hoger aantal ...

    Waarschuwing | 15-12-2023

  3. Becton, Dickinson and Company, IDS-23-4910, BD BACTEC™ MicroMGIT Calibration Vial

    Becton, Dickinson and Company has confirmed through 45 (forty-five) customer complaints that the BD BACTEC™ MicroMGIT™ ...

    Waarschuwing | 12-12-2023

  4. Actim Oy, 1698PARTUS, Actim Partus Test

    Our recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the Partus ...

    Waarschuwing | 11-12-2023

  5. Leica Biosystems Nussloch GmbH, CN-237848, Leica Biosystems Tissue processor

    As part of our post market surveillance, we have been made aware of an issue regarding poorly processed and/or damaged biopsy ...

    Waarschuwing | 11-12-2023

  6. Actim Oy, 1698PARTUS, Actim PROM Test, Actim PROM 1ngeni Test

    Our recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the PROM ...

    Waarschuwing | 11-12-2023

  7. LDN Labor Diagnostika Nord GmbH & Co. KG, DE/0000040010, Androstanediol-Glucuronide ELISA

    For the product AA E-1500 Androstanediol Glucuronides ELISA Lot 230083( it has been detected that the standards D (AA E-1504 Lot ...

    Waarschuwing | 08-12-2023

  8. QuidelOrtho (Ortho Clinical Diagnostics Inc), CL2023-257, ORTHO VISION and VISION Max Analyzers for BioVue

    The wash protocol for ORTHO Sera Anti-Jkb on the ORTHO VISION / VISION Max BioVue Analyzer does not sufficiently clean the ...

    Waarschuwing | 23-11-2023

  9. EPOCAL, POC 24-001, epoc NXS Host

    The epoc NXS Host was confirmed to display incorrect results in Test History, after printing, or when viewed on a Data Manager ...

    Waarschuwing | 17-11-2023

  10. Siemens Healthcare Diagnostics Inc., RAPIDPoint 500 Systems Measurement Cartridge

    Siemens Healthcare Diagnostics Inc. has confirmed an issue with RAPIDPoint 500 Systems Measurement Cartridges (with lactate).

    Waarschuwing | 17-11-2023