Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. 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

  2. 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

  3. Becton, Dickinson and Company, IDS-23-4859, BD BACTEC™ Plus Aerobic/F Culture Vials

    BD heeft via twee klachten van klanten bevestigd dat bepaalde flesjes van de hierboven vermelde BD BACTEC™ Plus ...

    Waarschuwing | 21-09-2023

  4. Beckman Coulter, Inc., FA 23026, Access Folate (Reagent Pack)

    Beckman Coulter heeft vastgesteld dat de reagenspipetten voor de DxI 9000 Access-immunoassay-analyser mogelijk niet volledig door ...

    Waarschuwing | 21-08-2023

  5. MED TRUST Handelsges.m.b.H., FSN-2023-01, Wellion LUNA TEST STRIPS 10 GLU

    Re·call Wellion LUNA duo/trio meter sets and teststrips. During an unannounced audit by TUV Rheinland it was detected that the ...

    Waarschuwing | 04-05-2023

  6. Biohit Oyj, 144-22, BIOHIT ColonView quick test

    lf the specified kit lot has been used, a minor possibility for a false negative result still exists. In such a case there would ...

    Waarschuwing | 30-12-2022

  7. Abbott Hematology, FA09SEP2022, Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module

    The Alinity h-series System Control Center (SCC) Application Software Version 4.3 (and below) and the Local User Interface (LUI) ...

    Waarschuwing | 27-09-2022

  8. Helena Biosciences NC476 - SAS Free Kappa_Lambda IEF Kit

    Further to customer feedback regarding the performance of the SAS Free Kappa IEF Kit: REF 102208 and SAS Free Lambda IEF Kit: REF ...

    Waarschuwing | 20-04-2022

  9. Abbott GmbH FA24MAR2022 - Alinity i Homocysteine Reagent Kit

    Abbott has identified that some reagent kits produce suboptimal calibrations resulting in a downward shift of quality control ...

    Waarschuwing | 19-04-2022

  10. IQ Products BV, FSN-FSCA-2020-01- INC323, FMH QuikQuant

    IQ Products BV meldt Filed Safety over FMH QuikQuant.

    Waarschuwing | 26-11-2020