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584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Siemens, VSW 22-01, Dimension Vista Systems

    Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays

    Waarschuwing | 03-12-2021

  2. Abbott Laboratories, FA29SEP2021_LM IRV, ARCH c8000, c16000, i2000SR, i1000SR

    Abbott has identified three potential performance issues for the ARCHITECT Software version 9.41 and earlier. 

    Waarschuwing | 29-10-2021

  3. Beckman Coulter, Inc., FA-000604, Access hsTnI Reagent (High Sensitivity Troponin I)

    In deze brief vindt u het laatste nieuws over mogelijke kruisbesmetting tussen analyses bij de Access hsTnI-test (hooggevoelige ...

    Waarschuwing | 29-10-2021

  4. Abbott Laboratories, FA29SEP2021_LM AP, ARCHITECT c4000 & ARCHITECT i2000

    Abbott has identified three potential performance issues for the ARCHITECT Software version 9.41 and earlier.

    Waarschuwing | 28-10-2021

  5. Radiometer Medical ApS, FSN-2021-10-07, D513 Disposable Waste Container

    Radiometer has become aware of a potential issue with the D513 Disposable waste container for the ABL800 analyzers (details ...

    Waarschuwing | 28-10-2021

  6. SSI Diagnostica A/S, Inc., Complaint no. 120-2021, ImmuView S. pneumoniae and L. pneumophila

    Due to a production error, the positive control is not correct.

    Waarschuwing | 08-10-2021

  7. Roche Diagnostics, CN-588981 (SBN-RDS-Molecular Lab-2021-011), cobas EGFR Mutation Test v2

    Roche received complaints reporting the generation of false Mutation Detected results for the exon20 insertion (Ex20Ins) mutation ...

    Waarschuwing | 27-08-2021

  8. Roche Diagnostics CN-603821 (SBN-RDS-POC-2021-010) - cobas SARS-CoV-2 & Influenza A/B Test

    Roche has received an increased number of complaints from customers when using cobas® SARS-CoV-2 & Influenza A/B Test for use on ...

    Waarschuwing | 30-07-2021

  9. Abbott Laboratories FA26JUL2021 - Alinity ci-series System Control Module (SCM)_FSN

    Abbott has identified three potential performance issues for the Alinity ci‐series Software version 3.2.3 and earlier. Abbott is ...

    Waarschuwing | 26-07-2021

  10. Bio-Rad_DiaMed GmbH FSCA 002-21 - ID-Antigen Profile II

    We would like to share information about an artefact visible prior to the use of the ID-Card that could be observed when using ...

    Waarschuwing | 19-07-2021

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