Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Siemens - Dimension Vista® 500 and 1500

   Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly ...

   Waarschuwing | 29-03-2017

2. Field Safety Notice: bioMérieux - NucliSENS® Lysis Buffer

   The investigation confirmed that the eluate becomes coloured because of the presence of the heme group from the haemoglobin ...

   Waarschuwing | 08-03-2017

3. Field Safety Notice: Hitachi High-Technologies Corporation, cobas® 8000 Operator’s Manual version 5.0

   The version 5.0 OM incorrectly states that 11 to 16 mm diameter NSTs may be used on cobas e 602 and cobas e 801 modules. ...

   Waarschuwing | 22-02-2017

4. Field Safety Notice: Randox Laboratories - Liquid Cardiac Control

   Randox has confirmed a change in recovery with regard to Myoglobin in the lots of the Liquid Cardiac Control listed above for the ...

   Waarschuwing | 17-02-2017

5. bioMérieux SA FSCA 3108 - Campylosel agar

   Due to the referenced issue there is a potential to have a misinterpretation of the results related to the growth of Enterobacter ...

   Waarschuwing | 02-08-2016

6. Alere CAPA-00000981 - Alere Afinion CRP

   Het bewaren van de bovengenoemde loten op kamertemperatuur (15-25 °C) heeft een invloed op het product. Het gebruik van de ...

   Waarschuwing | 22-07-2016

7. Siemens Healthcare Diagnostics Products GmbH PH-16-003 - BCS System, BCS XP Analyzer System, OVIO032, OVOB032

   Siemens Healthcare Diagnostics has observed that in very rare cases false short clotting times for PT on BCS and BCS XP with Dade ...

   Waarschuwing | 23-12-2015

8. Becton Dickinson BDB-15-657 - FMC7 FITC

   The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%. The adverse ...

   Waarschuwing | 17-12-2015

9. Beckman Coulter Ireland Inc.FSCA-26617, EU-011215-010 - DxH 800. Slidemaker Stainer and DxH 600

   During internal testing, Beckman Coulter determined that the software for the DxH systems noted above allows the creation of ...

   Waarschuwing | 01-12-2015

10. Field Safety Notice: Becton Dickinson and Company, BD Vacutainer® SST™ II Advance Plus Bloedafnamebuizen

    BD heeft bij interne controles een drukfout vastgesteld op de etiketten voor de buis, dozen en verzendkartons, met vermelding van ...

    Waarschuwing | 24-02-2017