Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Cepheid - Xpert CT/NG- test

   Wij willen er u op attenderen dat bij sommige van onze gebruikers er zich een hoger aantal "invalid" resultaten hebben ...

   Waarschuwing | 08-03-2017

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. Randox Laboratories Ltd REC270 - Evidence Investigator

   In response to operator feedback and in line with our policy of continuous improvement, the Evidence Investigator analyser ...

   Waarschuwing | 02-03-2017

4. Field Safety Notice: Roche - Sample Probe connector

   We regret to inform you that in very rare cases a disturbance of the sample liquid level detection (LLD) may occur due to a ...

   Waarschuwing | 02-03-2017

5. Alere - Alere Afinion™ CAPA-00001284 Lipid Panel Control

   Klachten van klanten over Control C I (lot 10184751). Er zijn meldingen gemaakt van geproduceerde resultaten die buiten de ...

   Waarschuwing | 01-03-2017

6. 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

7. Field Safety Notice: Trinity Biotech - Premier Buffer A_B Reagent

   We are writing to inform you that we have received reports of difficulty in recovering controls (QC verification), using the ...

   Waarschuwing | 23-02-2017

8. Field Safety Notice: Siemens Healthcare, ADVIA® Chemistry Systems

   Siemens Healthcare Diagnostics is providing an update to all ADVIA Chemistry Systems Lactate Dehydrogenase L-P (LDLP) and Lactate ...

   Waarschuwing | 22-02-2017

9. 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

10. Field Safety Notice: Hitachi High-Technologies Corporation, cobas® 8100 automated workflow series

    We regret to inform you that a rack crash may occur on the cobas® 8100 reformatter modules URF and BRF with software versions ...

    Waarschuwing | 20-02-2017