Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Siemens Healthcare Diagnostics Inc, POC 24-007, Atellica UAS 800 Analyzer

   Siemens Healthcare Diagnostics Inc. has confirmed an issue that has the potential to misidentify samples when ALL the following ...

   Waarschuwing | 27-03-2024

2. Siemens Healthcare Diagnostics Inc, Atellica CH Immunoglobulin

   Siemens Healthineers has confirmed the potential for a negative bias with quality control (QC) and patient sample results when ...

   Waarschuwing | 12-01-2024

3. Cepheid, 23FAR014, Xpert Xpress CoV-2/Flu/RSV plus

   Bepaalde laboratoria die de Xpert® Xpress CoV-2/Flu/RSV plus-test en de beoogde monstertypen gebruiken, hebben een hoger aantal ...

   Waarschuwing | 15-12-2023

4. Illumina, Inc., FSN-QI – 00632, NextSeq 550Dx Instrument / MiSeq Dx Instrument

   Illumina heeft een kwetsbaarheid in de cybersecurity aangetroffen die van toepassing is op de Local Run Manager (LRM)-software in ...

   Waarschuwing | 10-11-2023

5. Abbott Molecular, Inc., FA-AM-OCT2023-293, Alinity m HCV AMP Kit

   Abbott has identified an increase in potential for reactive negative controls as well as separate instances of false positive ...

   Waarschuwing | 09-11-2023

6. Siemens Healthcare Diagnostics Inc., POC 23-018, RAPIDPOINT 500 Blood Gas System and RAPIDPOINT 500e Blood Gas System

   Siemens Healthcare Diagnostics Inc. has determined that two drugs, Perhexiline Maleate and Atomoxetine Hydrochloride, may ...

   Waarschuwing | 27-10-2023

7. Diagnostic Grifols S.A., 800012097, ERYTRA EFLEXIS

   The analyzer may give incorrect interpretations of a profile that includes multiple techniques under certain conditions.

   Waarschuwing | 28-08-2023

8. Siemens Healthcare Diagnostics Inc., CHC 23-02, ADVIA Chemistry Iron_2 (IRON_2) Reagents

   Siemens Healthcare Diagnostics Inc. has confirmed, through investigation of customer complaints, the potential for a positive ...

   Waarschuwing | 28-08-2023

9. 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

10. 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