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  1. 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

  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. 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

  4. Olympus Medical Systems Corporation, QIL FY24-EMEA-29-FY24-EMEA-14-White Tape on Scope, Olympus Flexible Endoscopes

    Olympus recently received complaints indicating that the insertion tube of a repaired endoscope was wrapped with white tape. This ...

    Waarschuwing | 08-12-2023

  5. VOSTRA GmbH, 36063/23, U473, Rhinotamp und Rhinotamp latexfrei

    As part of the PMS activities, VOSTRA has become aware of a case of use with the product RHINOTAMP in which a user pulled on the ...

    Waarschuwing | 08-12-2023

  6. The Insides Company Limited, CFR-162, The Insides System

    As you may be aware, on the 12th of October a Driver overheated at a hospital in Europe. We traced it back to a small number of ...

    Waarschuwing | 08-12-2023

  7. Caesarea Medical Electronics Ltd., FSN-MMS-23-4881, BodyGuard™ Infusion Pumps Systems (LVP)

    Eerder heeft BD, in het kader van een Bericht inzake de veiligheid in het veld, referentie MMS-21-4135, als tijdelijke maatregel ...

    Waarschuwing | 07-12-2023

  8. Maquet Cardiopulmonary GmbH, 924014, Tubing Set, heart-lung bypass

    Maquet Cardiopulmonary GmbH received customer complaints for CTP reporting the perforation of the Tyvek, the upper part of the ...

    Waarschuwing | 07-12-2023

  9. Insulet Corporation, 9056196-11222023-001-C, Omnipod 5 Automated Insulin Delivery System

    Decimal/Comma separator entry failing to register when adjusting a bolus amount

    Waarschuwing | 07-12-2023

  10. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-26-FY24-OSTA-07, EZDilate Fixed Wire (Guided) Balloon

    Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving ...

    Waarschuwing | 07-12-2023