Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Fujirebio Europe NV, FSN-RE2020-001/HHE20-08, INNOTEST HIV Antigen mAb (96T)

    Decreased reactivity for serum / plasma samples.

    Waarschuwing | 12-10-2020

  2. Abbott FA28AUG2020 - ARCHITECT Galectin‐3 Reagent

    The purpose of this letter is to inform you of a product recall for ARCHITECT Galectin‐3 Reagent lot 10037M800. We have ...

    Waarschuwing | 28-08-2020

  3. Siemens POC 20-011 - Atellica 800_Atellica 1500

    Siemens Healthcare Diagnostics has confirmed that falsely depressed results may occur on Atellica UAS 800 systems using software ...

    Waarschuwing | 06-08-2020

  4. Abbott Diagnostics FA20JUL2020 - Alinity hq Analyzer

    This Product Correction letter is to inform you of a potential issue with the Alinity hq Analyzer which may impact the ...

    Waarschuwing | 20-07-2020

  5. Abbott GmbH, FSN-FA24APR2020, ARCHITECT iGentamicin Reagent Kit

    This letter is to inform you of a Product Correction for the ARCHITECT iGentamicin assay.

    Waarschuwing | 27-04-2020

  6. Siemens PH-20-009 - Coagulation Factor V Deficient Plasma

    Siemens Healthcare Diagnostics Products GmbH has confirmed that some packages of Coagulation Factor V Deficient Plasma lot 504974 ...

    Waarschuwing | 08-04-2020

  7. Axis-Shield Diagnostics FSCA079658 - Alere NT-proBNP

    The purpose of this letter is to inform you of a product recall for the Alere NT-proBNP Calibrator and Control lot numbers listed ...

    Waarschuwing | 09-03-2020

  8. Siemens ACHC20-07 - Atellica CH Ethyl Alcohol (ETOH) assay

    Siemens Healthcare Diagnostics Inc. investigation has confirmed that the Atellica CH ETOH assay may exhibit a positive bias in QC ...

    Waarschuwing | 28-02-2020

  9. Siemens Healthcare Diagnostics Inc. IMC 20-03 IMMULITE 2000/IMMULITE 2000 XPi EBV-VCA IgM

    Siemens Healthcare Diagnostics Inc. IMMULITE 2000/IMMULITE 2000 XPi EBV-VCA IgM Waarschuwing van de fabrikant Dit bericht is een ...

    Waarschuwing | 02-01-2020

  10. MediRox AB, 342, MRX Owren's PT

    Klanten die MRX Owren’s PT gebruiken, gereconstitueerd volgens de 1X-methode, hebben gemerkt dat er soms een foutmelding wordt ...

    Waarschuwing | 11-11-2019