Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Randox REC305 - Liquid Cardiac Control - Level 3

   Randox Laboratories has confirmed Troponin T and Troponin I levels in lot 4069CK have deteriorated. This may result in recovery ...

   Waarschuwing | 01-08-2017

2. Siemens CC 17-18 - Advia Centaur XPT System T3

   Siemens has identified an issue when scanning the 2D barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit ...

   Waarschuwing | 31-07-2017

3. Field Safety Notice: Hitachi High Technologies, cobas 8000 core unit

   We regret to inform you that we have identified a software limitation, which in rare cases resets your system configuration of ...

   Waarschuwing | 20-07-2017

4. Field Safety Notice: Magellan Diagnostics Inc., LeadCare

   In navolging van de veiligheidsmededeling van de Amerikaanse Food and Drug Administration (FDA), strekt deze mededeling ten doel ...

   Waarschuwing | 19-07-2017

5. Field Safety Notice: Becton Dickinson, BD MAX Vaginal Panel -UVE Specimen Collection Kit

   The following information is intended to provide clinicians and patients with precautions in relation to current Instructions For ...

   Waarschuwing | 19-07-2017

6. Siemens PP-17-013 - N Antiserum to Human Ig/L-chain, LAMBDA-type en N Antiserum to Human Ig/L-chain, Î type

   Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -26% for results obtained with N Antiserum to Human ...

   Waarschuwing | 17-07-2017

7. Field Safety Notice: Alere - Alere HIV Combo

   Onze interne onderzoeken hebben aangetoond dat, wanneer EDTA-volbloedmonsters worden getest, de bovenstaande lotnummers vaker een ...

   Waarschuwing | 14-07-2017

8. Field Safety Notice: Roche - cobas c 501 and c 502 module

   We regret to inform you that an operator was injured during a maintenance task, when removing the Ultrasonic Mixer Cover (USM ...

   Waarschuwing | 11-07-2017

9. Field Safety Notice: Siemens - ADVIA_VISTA_SYVA

   Siemens Healthcare Diagnostics has become aware of sulfasalazine and sulfapyridine drug interference in the assays which use NADH ...

   Waarschuwing | 05-07-2017

10. 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