Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. ELITech Clinical Systems SAS, FSN-2306VIG01, LACTATE

   In extreme Lactic Acidosis, Lactate levels may rise to >5 mmol/L (45 mg/dL), hence the revised range, in combination with the ...

   Waarschuwing | 20-07-2023

2. Beckman Coulter Inc.,FA 23026, Access Folate Reagent Pack

   Beckman Coulter heeft vastgesteld dat de reagenspipetten voor de DxI 9000 Access-immunoassay-analyser mogelijk niet volledig door ...

   Waarschuwing | 12-07-2023

3. QuidelOrtho Ortho Clinical Diagnostics Inc, CL2023-145, ORTHO VISION and VISION Max Analyzers for BioVue

   There may be a risk to patient results if ORTHO Sera Anti-N was processed on an analyzer where it is not validated, and the ORTHO ...

   Waarschuwing | 06-07-2023

4. Siemens Healthcare Diagnostics Products GmbH, PH-23-001-A-C, Test Thrombin Reagent

   Siemens Healthcare Diagnostics Products GmbH received complaints regarding control recovery issues for Test Thrombin Reagent kit ...

   Waarschuwing | 06-07-2023

5. Beckman Coulter Biomedical GmbH, FA 23024, DxA 5000 Automation System

   De DxA-software heeft configuratie-instellingen voor het identificeren van tests die niet moeten worden uitgevoerd op basis van ...

   Waarschuwing | 06-07-2023

6. Hamilton Bonaduz AG, FSCA-2023-01, CO-RE Tips CO-RE II Tips

   As root cause the filter has been identified. Said filter is being inserted into to the tip during production.

   Waarschuwing | 16-06-2023

7. Beckman Coulter, Inc., FSN-FA 23021, DxI 9000 Access Immunoassay Analyzer

   Beckman Coulter heeft vastgesteld dat de hierboven vermelde softwareversie van de DxI 9000 Access-immunoassay-analyser het aantal ...

   Waarschuwing | 08-06-2023

8. Abbott Diagnostics Technologies AS, FSN-CAPA-00005233, Alere Afinion 2 Afinion 2

   Abbott has identified an issue related to overheating of Afinion 2 instruments with software version ≤ 21.13. 

   Waarschuwing | 08-06-2023

9. EUREKA SRL LAB DIVISION, FSN-01/2023, Noradrenalina IVD, calibrator and control

   A thorough examination at customer site of the calibrator performance showed that the Noradrenaline values were overestimated.  ...

   Waarschuwing | 08-06-2023

10. QIAGEN GmbH, FSN-CI 3028397, QIAstat-Dx® Respiratory SARS-CoV-2 Panel

    Deze dringende veiligheidsmededeling dient om u erover te informeren dat QIAGEN heeft vastgesteld dat bepaalde partijen van de ...

    Waarschuwing | 08-06-2023