Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Abbott Diagnostics FA19JUN2020 - Alinity ci-series System Control Module (SCM)

   Abbott has identified two issues with Quality Control (QC) functionality, after an assay file update, that impacts all Alinity ...

   Waarschuwing | 19-06-2020

2. Abbott Diagnostics FA18JUN2020 - Alinity h‐series (Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module)

   Abbott has identified the following issues in Software Version 4.2 and below, which will be corrected in Software Version 4.3 ...

   Waarschuwing | 18-06-2020

3. Roche Molecular Systems, FSN-CN-494142 (SB-RMD-2020-001), MagNA Pure 96 System

   As a result of a customer complaint, it was discovered that, only when using the Sample Transfer protocol version 3.0 on the ...

   Waarschuwing | 05-06-2020

4. Siemens Healthcare Diagnostics Inc, FSN-ACHC 20-06, Fructosamine en Enzymatic Creatinine_2 assay op Atellica CH Analyzer

   The purpose of this communication is to inform you of an interference identified with the indicated products and to provide ...

   Waarschuwing | 28-05-2020

5. NORMAND-INFO S.A.S.U. FA-20022 Remisol Advance

   Bij de hematologietestpanels WBC, UWBC en PLT worden de resultaten van een herhaalde run verwijderd in RADV wanneer bepaalde ...

   Waarschuwing | 12-05-2020

6. Fast-Track Diagnostics S.a.r.l., FSN-FA-2020-04, FTD Stool parasites

   Update van de gebruiksaanwijzing voor de FTD Stool parasites-kit.

   Waarschuwing | 08-05-2020

7. Radiometer Medical ApS, FSN-FAN 915-412, ABL800 with FlexQ

   Radiometer has become aware that there is a potential risk of patient mix-up on ABL800 analyzers with FLEXQ sampler tray.

   Waarschuwing | 06-05-2020

8. Phadia AB, FSN-QA2020-02, EliA Stool Extraction Kit (see section 8)

   The purpose of this letter is to advise you that Phadia AB, part of Thermo Fisher Scientific, is issuing a Field Safety ...

   Waarschuwing | 01-05-2020

9. Becton Dickinson and Company, FSN-IDS-20-1985, BD BBL™ Gram Crystal Violet 250mL & Grain Stain Ki

   BD is issuing this Field Safety Notice to remove one specific lot of BD BBL™ Gram Crystal Violet 250mL and one specific lot of BD ...

   Waarschuwing | 28-04-2020

10. Abbott GmbH, FSN-FA24APR2020, ARCHITECT iGentamicin Reagent Kit

    This letter is to inform you of a Product Correction for the ARCHITECT iGentamicin assay.

    Waarschuwing | 27-04-2020