Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Genrui Biotech Inc., FSN-GR220105-1, SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

   Naar aanleiding van meldingen van vals-positieve voorvallen met de SARS-CoV-2-antigeentestkit (Colloïdaal Goud) voor zelftesten, ...

   Waarschuwing | 17-01-2022

2. VigoMed Medizintechnik GmbH, FSN-18139/21, ideFixx Microplates and -screws

   The titanium implants are non-magnetic and MR-safe up to 1.5 Tesla (standard MRI devices). There is no risk from the magnetic ...

   Waarschuwing | 10-01-2022

3. Bauerfeind AG, FSN-DE-MF-000007543, MOS-Genu; entspricht

   The aluminum frame of the MOS-Genu knee orthosis (short and long versions) does not have the required material rigidity. That ...

   Waarschuwing | 07-01-2022

4. Maillefer Instruments Holding SARL, FSN-HHE-2021-05, PATHFILE; PROGLIDER; PROTAPER GOLD

   During regular internal testing, Dentsply Sirona has detected a sporadic sealing issue on a production of blisters. Some of these ...

   Waarschuwing | 31-12-2021

5. Diatesse_GD Medical Pharma B.V. FSCA GD101905 - Diatesse XPER Bloedglucose & Ketonen controlesysteem mg/dL

   Abusievelijk zijn in de periode tussen 27 oktober 2021 en 10 november 2021 Diatesse XPER Bloedglucose & Ketonen controlesystemen ...

   Waarschuwing | 01-12-2021

6. Abbott Diagnostics, FSCA 2021-10, ID NOW COVID-19 24 Test Kit

   Our records show that you have received ID NOW COVID-19 24 T Kit Lot(s) mentioned above, which contains foam Patient Swabs that ...

   Waarschuwing | 23-11-2021

7. S.B.M. SAS, FSN-FNCONF-21-0101, ComposiTCP 30 Interference screw - D 7- L:25 mm; cannula 1.2m

   SBM has initiated a voluntary product recall concerning a reference of ComposiTCP Interference screws. According to our ...

   Waarschuwing | 17-11-2021

8. Hager & Werken FSCA 04-2021-01 - Fit Rubber Dam Clamp

   An increasing number of breakages in the clamps occurred within/during above-mentioned period. These breakages may be related to ...

   Waarschuwing | 08-11-2021

9. Sentec AG CAPA 0550 - NeoContactAgent (Kit)

   An issue has been identified with the NeoContactAgent (sold as NeoContactAgent Kit) which could pose a potential risk to patients.

   Waarschuwing | 03-11-2021

10. Beckman Coulter, FA-21045, DxA 5000

    Beckman Coulter heeft meldingen ontvangen van monsterrekken (met of zonder monsters) die naar de buitenste baan van het ...

    Waarschuwing | 08-10-2021