Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. BEMER International AG, FSN-UQ-6232, BEMER Classic und Pro Set

   BEMER Int. AG has become aware of cases in which a causal link between the use of the BEMER therapy system and a technical defect ...

   Waarschuwing | 14-12-2020

2. Covidien llc, FSN-FA942, TATM Auto SutureTM Vascular Loading Unit with DST SeriesTM Technology 30mm -V3, TA™ Auto SutureTM Vascular Stapler with DST SeriesTM Technology 30mm -V3

   Deze brief dient om u te informeren dat Medtronic specifieke productiepartijen terugroept van de Covidien TA™ Auto Suture ...

   Waarschuwing | 30-11-2020

3. 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

4. Corvia Medical, Inc., FSN-FSCA-02-2020-09-28, InterAtrial Shunt Device (IASD) System II

   VEILIGHEIDSBULLETIN – InterAtrial Shunt Device (IASD)-systeem II.

   Waarschuwing | 06-10-2020

5. Mikrogen GmbH, FSN-DE/202002, recomLine SARS-CoV-2 IgG [Avidität]

   Herewith Mikrogen GmbH is informing you about a misprint on the outer kit box label of our product  recomLine SARS-CoV-2 IgG ...

   Waarschuwing | 22-09-2020

6. ThermoFisher Scientific PR430820 - COVID-19 CE-IVD Interpretive Software v1.3 and 2.3_update FSN

   In the previous FSN, we communicated that the MS2 assay which detects the Internal Positive Control (IPC), may produce ...

   Waarschuwing | 19-08-2020

7. Natus Medical Incorporated, FSN-CAPA004899, Embletta Gold USB Cable

   Natus Medical Incorporated voert een vrijwillige terugroeping uit van de Embletta Gold USB-kabel.

   Waarschuwing | 06-08-2020

8. Mikrogen GmbH, FSN-DE/202001, recomWell Helicobacter IgA

   Our quality control and customer feedback management revealed, that the above mentioned batch contains cut-off control and ...

   Waarschuwing | 24-06-2020

9. Sunrise Medical QA07204 - Shark Power Module

   Shark Power Modules manufactured between January 2019 and August 2018 may be susceptible to broken Actuator FET Spring Clips due ...

   Waarschuwing | 19-06-2020

10. lsiomedicca Medizinprodukte GmbH, FSN-IINC-AT-20-02-000002, Anti C4d

    lsiomedicca Medizinprodukte GmbH would like to inform you that the antibody from this specific anti-C4d Antibody lot (# RCD191) ...

    Waarschuwing | 26-05-2020