Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. BioFire Diagnosticss, LLC, FSCA 5761-2, BIOFIRE FILMARRAY TORCH Base

   bioMérieux heeft een verhoogd risico vastgesteld op degradatie van de voedingsingangschakelaar van de TORCH-basis. Dit verhoogde ...

   Waarschuwing | 02-07-2024

2. Biocartis, BC-023637, IdyllaTM EGFR Mutation Test

   Biocartis has identified the potential for False Positive (FP) results to be generated for the S7681 target when using the ...

   Waarschuwing | 17-06-2024

3. Leica Biosystems Nussloch GmbH, CN-251519, HistoCore Pegasus / HistoCore Pegasus Plus

   The overfilling of reagents by users, excess reagent carried from the basket during initial loading, or excessive reagent in the ...

   Waarschuwing | 23-04-2024

4. Hologic Inc., FA-00242, Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

   While testing the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay on Panther Fusion System, there is a potential risk of a false Flu ...

   Waarschuwing | 25-03-2024

5. DiaSorin Italia S.p.A., FSN-110324, LIAISON® BRAHMS PCT® II GEN

   In the Istructions for Use (IFU) associated to the lot 239036 there is an error in the list of the validated matrices that can be ...

   Waarschuwing | 14-03-2024

6. BioFire Diagnostics, LLC, FSCA 5812, FilmArray® Gastrointestinal (GI) Panel

   The purpose of this letter is to inform you of a product recall (correction) involving the BIOFIRE® FILMARRAY® Gastrointestinal ...

   Waarschuwing | 15-02-2024

7. Randox Laboratories Ltd., REC701, CALIBRATION SERUM LEVEL 3 (CAL 3)

   Randox Laboratories kan bevestigen dat de doelstelling voor Alkalische Fosfatase (ALP) voor de AMP geoptimaliseerd tot IFCC 37 ...

   Waarschuwing | 04-01-2024

8. EPOCAL, POC 24-001, epoc NXS Host

   The epoc NXS Host was confirmed to display incorrect results in Test History, after printing, or when viewed on a Data Manager ...

   Waarschuwing | 17-11-2023

9. Siemens Healthcare Diagnostics Inc., RAPIDPoint 500 Systems Measurement Cartridge

   Siemens Healthcare Diagnostics Inc. has confirmed an issue with RAPIDPoint 500 Systems Measurement Cartridges (with lactate).

   Waarschuwing | 17-11-2023

10. BioMérieux SA, FSCA #5773, BK VIRUS R-GENE; EBV R-GENE

    Following complaints from the field related to low positive signals (aspecific signals below Ct corresponding to the limit of ...

    Waarschuwing | 03-08-2023