Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. BÜHLMANN Laboratories AG, FSN-01.2020, BÜHLMANN GanglioCombiTM MAG ELISA

   Niet-specifieke storing veroorzaakt door grondstof (natriumchloride) die wordt gebruikt bij de productie van BÜHLMANN ...

   Waarschuwing | 16-10-2020

2. Ortho Clinical Diagnostics Inc, FSN-CL2020-206, ORTHO VISION and VISION Max Analyzers

   This notification is regarding the potential for intermittent false positive results being generated on ORTHO VISION® or ORTHO ...

   Waarschuwing | 17-08-2020

3. Roche Diagnostics CN-494220 - Elecsys PTH (1-84)

   The issue observed is a calibration signal for calibrator level 2 varying between two signal levels: ~25’000 cts vs ~35’000 cts. ...

   Waarschuwing | 17-07-2020

4. MarDx Diagnostic, R009-20, Uni-Gold S pneumoniae

   Ontoereikendheid in de gebruiksaanwijzing van het product, - gedeelte over beoogd gebruik.

   Waarschuwing | 29-06-2020

5. Abbott Diagnostics FA19JUN2020 - Alinity ci-series System Control Module (SCM)

   Abbott has identified two issues with Quality Control (QC) functionality, after an assay file update, that impacts all Alinity ...

   Waarschuwing | 19-06-2020

6. Abbott Diagnostics FA18JUN2020 - Alinity h‐series (Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module)

   Abbott has identified the following issues in Software Version 4.2 and below, which will be corrected in Software Version 4.3 ...

   Waarschuwing | 18-06-2020

7. Siemens Healthcare Diagnostics Inc, FSN-ACHC 20-06, Fructosamine en Enzymatic Creatinine_2 assay op Atellica CH Analyzer

   The purpose of this communication is to inform you of an interference identified with the indicated products and to provide ...

   Waarschuwing | 28-05-2020

8. Abbott Diagnostics CAPA-2386 - Power supply provided with Afinion™2 and Alere Afinion™ AS100 Analyzer

   Abbott has received complaints for the Afinion Analyzer systems related to electrostatic discharge and sparking of the power ...

   Waarschuwing | 23-03-2020

9. Siemens Healthcare Diagnostics Inc ASW20-03 Atellica CH 930 Analyzer

   Editing an assay Test Definition and switching to another assay’s Test Definition screen without saving the changes using the ...

   Waarschuwing | 27-02-2020

10. Siemens PH-20-006 - Dade Ci-Trol 1

    Siemens Healthcare Diagnostics has observed that assigned confidence intervals for Fibrinogen are broader than expected. This ...

    Waarschuwing | 26-02-2020