Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Wallac Oy, R2019003, GSP Neonatal IRT kit

   External quality assurance e.g. proficiency test samples may contain citrate or EDTA and therefore the measured IRT analyte ...

   Waarschuwing | 13-12-2019

2. Stago RC-19-0049 STA® Unicalibrator

   Following a customer complaint, Stago has investigated and confirmed a positive bias on the (STA) Unicalibrator levels on test ...

   Waarschuwing | 13-11-2019

3. RAL Diagnostics, NC 19/077, NC 19/080 et NC 19/111- CE.101, Giemsa Solution

   Concerning Giemsa Solution lot I88021, lot I97523 and lot I63818 which have a staining defect, 3 cases may appear during the use ...

   Waarschuwing | 11-11-2019

4. MediRox AB, 342, MRX Owren's PT

   Klanten die MRX Owren’s PT gebruiken, gereconstitueerd volgens de 1X-methode, hebben gemerkt dat er soms een foutmelding wordt ...

   Waarschuwing | 11-11-2019

5. Siemens Healthcare, PH-20-001, Thromborel S

   Siemens Healthcare Diagnostics Products GmbH has confirmed that Thromborel S lot 565662 is showing a decreased on-board stability ...

   Waarschuwing | 06-11-2019

6. Roche Diabetes Care, SB_RDC_2019_06, Accu-Chek Aviva, Performa BGM

   This is why we would like to inform you today about a potential issue that might occur in Accu-Chek Aviva / Accu-Chek Performa ...

   Waarschuwing | 06-11-2019

7. Beckman Coulter, FA-000316, iChem VELOCITY Urine Chemistry Analyzer

   Hierdoor wordt de activering van de chemistry system flag ‘S3’ voorkomen en dat kan leiden tot foutieve resultaten voor het ...

   Waarschuwing | 04-11-2019

8. Beckman Coulter, FA-000152, iQ200 Series Urine Microscopy Analyzer, iChemVELOCITY Urine Chemistry System

   Klanten hebben incidenten gemeld waarbij twee resultaatreeksen dezelfde monsteridentificatiecode (monster-ID) rapporteren met ...

   Waarschuwing | 04-11-2019

9. Becton Dickinson GmbH BDDS-19-1857 BD CHROMagar™ Orientation Medium

   BD has recently become aware through customer feedback of bacterial contamination on the above listed lots of non-sterile ...

   Waarschuwing | 31-10-2019

10. Radiometer Medical, FAN 915-402, AQT90 FLEX analyzer

    Radiometer has become aware that certain Lots of Cleaning Solution tubes for the AQT90 FLEX has been produced with an incorrect ...

    Waarschuwing | 30-10-2019