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  1. Aesculap AG, FSN-FSCA249, AESCULAP AEOS

    With this letter Aesculap AG would like to inform you about a potential malfunction of product Aesculap Aeos®.

    Waarschuwing | 20-10-2020

  2. Medtronic, Inc., FSN-FA927, Rashkind® Balloon Septostomy Catheters

    Terugroepactie Rashkind-ballonseptostomiecatheters.

    Waarschuwing | 20-10-2020

  3. Mölnlycke Health Care AB, FSN-2020-09 (01), Mölnlycke® Procedure Trays & Single Packed Shielded Bladed Trocars

    Mölnlycke has become aware of situations where the protective flanges come away from trocar cannula.

    Waarschuwing | 19-10-2020

  4. Mölnlycke Health Care AB, FSN-2020-09 (02), TUR tray

    Mölnlycke has identified a potential safety issue. During a regular inspection, a fault in the sealing machine was identified.

    Waarschuwing | 19-10-2020

  5. BÜHLMANN Laboratories AG, FSN-01.2020, BÜHLMANN GanglioCombiTM MAG ELISA

    Niet-specifieke storing veroorzaakt door grondstof (natriumchloride) die wordt gebruikt bij de productie van BÜHLMANN ...

    Waarschuwing | 16-10-2020

  6. Merz Pharmaceuticals FSCA 2020-002 - Etermis 3 and Etermis 4

    For our Etermis 3/ Etermis 4 products, we recently implemented additional quality controls determined the presence of particles ...

    Waarschuwing | 16-10-2020

  7. Mauna Kea Technologies, FSN-UA 20-001, CystoFlex UHD R

    Mauna Kea Technologies communicates this safety notice concerning the medical device confocalnminiprobe™: CystoFlex™ UHD R.

    Waarschuwing | 16-10-2020

  8. Rocket Medical, FSN-INT COMP 127, Rocket FBS Kit for Lactate with Sampling Wand

    Rocket Medical is conducting a product correction safety alert concerning the Rocket FBS Kit for Lactate with Sampling Wand ...

    Waarschuwing | 16-10-2020

  9. Luminex Corporation, FSN-RC-20-017, all Verigene Assays

    Luminex Technical Support detected an increase in complaints for No Call Variation, No Background and No Call Negative Control ...

    Waarschuwing | 15-10-2020

  10. Siemens Healthcare Diagnostics Inc, FSN-ACHC 20-18, ADVIA and Atellica Fructosamine reagent

    The purpose of this communication is to inform you of a positive bias with Quality Control (QC) and patient samples when using ...

    Waarschuwing | 15-10-2020