Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Sentinel - MULTIGENT Creatinine (Enzymatic) assay

   Sentinel has detected a performance issue with the reagent 1 component of the three impacted lots listed above. This issue may ...

   Waarschuwing | 22-05-2017

2. Field Safety Notice: STEPHANIX, D2RS

   We hebben een potentieel risico vastgesteld dat kan leiden tot een botsing tussen de tafelkolom en de plafondstructuur, wat kan ...

   Waarschuwing | 22-05-2017

3. Field Safety Notice: ViCentra B.V., Kaleido Insulin Infusion System

   Through investigation we have found that the insulin cartridge component of the Kaleido System was under delivering. Fabrikant: ...

   Waarschuwing | 22-05-2017

4. Field Safety Notice: ArcRoyal, Custom Procedure Trays

   Medtronic voert een vrijwillige veiligheidsactie uit voor specifieke partijen Polysorb-hechtingen. Aanleiding voor deze ...

   Waarschuwing | 19-05-2017

5. Field Safety Notice: Abbott - Thoratec Corporation, HeartMate 3™ Left Ventricular Assist System

   Abbott heeft gevallen geconstateerd waarin de buigontlasting van de uitstroomcanule (OGBR – Outflow Graft Bend Relief) van het ...

   Waarschuwing | 18-05-2017

6. Field Safety Notice: Beckman Coulter, Access Total T3, Access Thyroglobulin, Access Free T4

   Beckman Coulter has determined through customer feedback and an internal investigation that the four Access immunoassays listed ...

   Waarschuwing | 17-05-2017

7. Field Safety Notice: GE Healthcare, Carestation 620, 650 en 650c

   Mogelijkheid tot verhoogde FiCO2 en onverwachte systeemstoring van Carestation 620, 650 en 650c Fabrikant: GE Healthcare Product: ...

   Waarschuwing | 16-05-2017

8. 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

9. Field Safety Notice: Microgenics Corporation, Application Sheets

   During an internal assessment we found that Application Sheets provided by Microgenics for expanded use of some Assays are ...

   Waarschuwing | 16-05-2017

10. Field Safety Notice: BRAHMS GmbH, part of Thermo Fisher Scientific, B•R•A•H•M•S anti-Tgn RIA

    During additional quality control testing we observed for B•R•A•H•M•S anti-Tgn RIA lot 127137, lot 134428 and lot 141439 an ...

    Waarschuwing | 15-05-2017