Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Analyzer versions 1.0.0, 1.1.0 and 1.4.0.0.0.1 of the FluoroType HSV VER 1.0

   In the FluoroCycler Report and in the result window of the Fluoro-Software IVD (tab 'Results HSV") Analyzer versions 1.0.0, 1.1.0 ...

   Waarschuwing | 02-06-2017

2. Field Safety Notice: Beckman Coulter - DxH 500 REF B40601, SW 1.0.2

   As a result of internal investigations, BEC has become aware that when the instrument temperature is exceeded, the DxH 500 allows ...

   Waarschuwing | 02-06-2017

3. Field Safety Notice: Siemens - RAPIDLab 348 and RAPIDLab 348EX

   Siemens Healthcare has received a number of reports of gas cartridges failing to install on the RAPIDLab 348 and RAPIDLab 348EX ...

   Waarschuwing | 31-05-2017

4. Field Safety Notice: Beckman Coulter - Synchron Systems AQUA Cal 1

   Beckman Coulter has confirmed a negative shift of 5 mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with ...

   Waarschuwing | 31-05-2017

5. Field Safety Notice: bioMerieux, VITEK® 2 - Colistin (cs01n) Performance

   A performance issue has been identified with colistin (cs01n) Fabrikant: bioMerieux Product: VITEK® 2 - Colistin (cs01n) ...

   Waarschuwing | 22-05-2017

6. 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

7. 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

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