Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: ThermoFisher - Phadia 1000

   This issue can occur with all Phadia 1000 instruments (article number 12-3800-01) and ISW versions since the introduction of the ...

   Waarschuwing | 30-06-2017

2. Field Safety Notice: QIAGEN - QIAamp DSP Virus-kit

   Uit onderzoek is gebleken dat het probleem is veroorzaakt door een afwijking van de juiste bewaarcondities. Dit heeft geleid tot ...

   Waarschuwing | 22-06-2017

3. Field Safety Notice: Roche Diagnostics, Cobas P512 and CobasP612 pre-analytical system

   Roche Diagnostics received complaints from two customers that un-spun samples were incorrectly identified as “spun” by the spin ...

   Waarschuwing | 16-05-2017

4. Field Safety Notice: Roche Diagnostics, cobas® MPX Test, CE-IVD, cobas® DPX Test, CE-IVD

   Under specific conditions, there is a possibility that Target specific results sent to a customer’s LIS may not match those ...

   Waarschuwing | 10-05-2017

5. Field Safety Notice: Siemens Healthcare, ADVIA Centaur Systems Insulin Assay

   Siemens Healthcare Diagnostics is providing this Urgent Field Safety Notice to communicate the restoration of the ADVIA Centaur ...

   Waarschuwing | 26-04-2017

6. Field Safety Notice: bioMérieux, VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards referenced in Appendix A

   A potential issue was identified related to the white pouch which contains VITEK® 2 test cards for the product lots specified in ...

   Waarschuwing | 20-04-2017

7. Field Safety Notice: bioMérieux - Etest ETP32 (Ertapenem)

   Based on the strain epidemiology evolution with the detection of some Streptococcus resistant strains from clinical specimens ...

   Waarschuwing | 05-04-2017

8. 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

9. 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

10. Field Safety Notice: DiaMed GmbH, ID-DiaCell's

    We would like to share with you, and your team, information about unexpected reactions primarily on eluates and QC samples but ...

    Waarschuwing | 10-02-2017