Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. AB SCIEX Pte. Ltd., FSCA-2023-177083, 4500MD and Citrine LC-MS/MS Systems

   In rare occasions, the combination of a leak of a highly flammable solvent at the ion source pro be, and an electrical discharge ...

   Waarschuwing | 21-08-2023

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 | 21-08-2023

3. Siemens Healthcare Diagnostics Inc., CHC 23-01, ADVIA Chemistry Urinary.Cerebrospinal Fluid Protein

   Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

   Waarschuwing | 14-08-2023

4. 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

5. Randox Laboratories Ltd., FSN-REC679, LIQUID URINE CONTROL LEVEL 2

   Randox Laboratories is conducting a Device Recall for Liquid Urine Controls Level 2, UC5074, lot 1209UC due to the following:  ...

   Waarschuwing | 24-07-2023

6. 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

7. 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

8. 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

9. 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

10. 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