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  1. CareDx AB, A-2022-013, Olerup SSP HLA-A low

    In totaal hebben drie klanten een mislukte interne controle en HLA-specifieke amplificaties gemeld in meerdere putten in de ...

    Waarschuwing | 10-03-2023

  2. SINOVO health solutions, FSCA_mylifeApp2.1.1, mylife App

    We would like to inform you of a software defect in the mylife App that might have an impact on patient safety.  

    Waarschuwing | 09-03-2023

  3. Beaver Visitec International LTD., FSN-FA-22-008, BVI CustomEyes Packs

    De BVI CustomEyes® verpakkingen van instrumenten, ook bekend als de BVI verpakkingen voor instrumenten voor oogchirurgische ...

    Waarschuwing | 09-03-2023

  4. 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

  5. Radiometer Medical ApS., FSN-FAN 915-424, AQURE system

    AQURE System – possible incorrect reply on patient queries from LumiraDx device. Radiometer has become aware of a potential ...

    Waarschuwing | 09-03-2023

  6. Hamilton Medical AG, FSN-CER 101091, HAMILTON-C6

    Safety ventilation can be triggered by switching to an adaptive mode. The display can be restarted by changing the Target Shift ...

    Waarschuwing | 09-03-2023

  7. Philips Medical Systems Nederland, 2022-IGT-BST-012, SmartPerfusion OWB, 2D Perfusion OWB

    Philips has identified through an internal investigation that SmartPerfusion and 2D Perfusion have technical issues related to ...

    Waarschuwing | 08-03-2023

  8. Remote Diagnostic Technologies, 2022-CC-EC-017, Tempus Pro Patient Monitor

    However, testing revealed that the device does not meet the standards for Fluid and Particulate lngress.

    Waarschuwing | 08-03-2023

  9. Zimmer Switzerland Manufacturing GmbH, ZFA2022-00302, CoCr Femoral Heads

    Zimmer GmbH is conducting a medical device Field Safety Corrective Action (correction) to update the compatibility matrix as ...

    Waarschuwing | 08-03-2023

  10. EUROS, FSN-FSCA-2023-02, NEMOST - Growing Domino - ø 5.5 mm

    Following one customer complaints, we have noted that the locking ring on the notched rod of the NEMOST device was not tight ...

    Waarschuwing | 07-03-2023

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