Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Microbiologics Inc, FSN-Recall 2020-007 0894 and 5249P, KWIK-STIK™ 0894P/ 0894K Microsporum canis & 5249P

    Dringend bericht inzake de Catalogus 0894P, 0894K en 0894L Microsporum canis afgeleid van ATCC® 36299™.

    Waarschuwing | 15-01-2021

  2. Tcoag Ireland Ltd, FSN-Event-2244, Destiny Max, DT 100

    This Field Safety Notice (FSN) is about a potential risk of contamination by Emicizumab - of Factor VIII assays on the Tcoag DT ...

    Waarschuwing | 13-01-2021

  3. ABBOTT POINT OF CARE, FSN-APOC2020-007, i-STAT CG8+ and EG7+ Cartridges

    This letter contains important information regarding the i-STAT® CG8+ and EG7+ cartridges.

    Waarschuwing | 23-12-2020

  4. Siemens Healthcare Diagnostics ASW 21-02 - Atellica IM 1300_1600 and CH 930 Analyzer

    Siemens Healthcare Diagnostics has identified the following issues with the Atellica Solution products listed in Table 1, which ...

    Waarschuwing | 22-12-2020

  5. Ortho Clinical Diagnostics CL2020-275 - ORTHO VISION® (Max) Analyzer

    As part of a Urgent Field Safety, the purpose of this notification is to inform you that due to a software anomaly on ORTHO ...

    Waarschuwing | 21-12-2020

  6. Leica Biosystems Newcastle Ltd, FSN-IR26/20, Novocastra™ Liquid Mouse Monoclonal Antibody N-Ca

    Leica Biosystems brengt dit dringende Bericht uit om u op de hoogte brengen van een corrigerende actie in verband met de ...

    Waarschuwing | 15-12-2020

  7. Siemens Healthcare Diagnostics Inc, FSN-ACHC 21-02, ADVIA and Atellica GGT reagent

    The purpose of this communication is to inform you of an issue with the ADVIA and Atellica GGT reagent.

    Waarschuwing | 11-12-2020

  8. Radiometer Medical ApS., FSN-FAN 915-414, AQT90 FLEX analyzers

     Radiometer has become aware of a potential issue with AQT90 FLEX analyzers with serial numbers of 393-838R0564 onwards.

    Waarschuwing | 10-12-2020

  9. The Binding Site Group Limited, FSN-AE051, Optilite Freelite Kappa Free Kits

    The Binding Site Group Limited meldt veiligheidsbericht over de Optilite Freelite Kappa Free Kits.

    Waarschuwing | 02-12-2020

  10. Actim Oy, FSN-240002483, Actim CRP

    Actim Oy has observed that in occasional Actim CRP dipsticks, the third test line (>80 mg/L) is lighter than specified.

    Waarschuwing | 02-12-2020