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Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Radiometer FAN 915-407 - ABL800 analyzers

    Radiometer has received a few reports of occurrences where the ABL800 barcode reader has misinterpreted the contents of a locally ...

    Waarschuwing | 21-02-2020

  2. Biocartis BC-013089 - Idylla™ EGFR Mutation Test

    The Idylla™ EGFR Mutation Test Instructions for Use (IFU) has been updated based on customer feedback and a request received from ...

    Waarschuwing | 20-02-2020

  3. BioMerieux Inc FSCA 4654 - VITEK® 2 AST-N371 TEST KIT 20 CARDS

    A potential issue was identified relating to the top seal of card pouches for the VITEK® 2 test card lot AST-N371 0210932204. ...

    Waarschuwing | 19-02-2020

  4. BioFire_bioMérieux FSCA 4593 - BioFire FilmArray® Blood Culture Identification (BCID) panel tests

    The purpose of this letter is to inform you that BioFire Diagnostics, LLC has identified an increased risk of false positive ...

    Waarschuwing | 06-02-2020

  5. Siemens IMC 19-07 - Immulite Progesterone - update FSN

    Siemens Healthcare Diagnostics Inc. issued Urgent Field Safety Notice IMC19-07.A.OUS in July 2019 to inform you of a potential ...

    Waarschuwing | 31-01-2020

  6. Roche CN-487470 - Elecsys CA 19-9

    We recently received an increased number of complaints concerning non-reproducible elevated results (so-called “high flyers”) for ...

    Waarschuwing | 24-01-2020

  7. bioMérieux FSCA 4613 - NUCLISENS® Lysis Buffer

    Following a customer complaint about colored eluates, bioMérieux investigation has confirmed an issue with this specific lot ...

    Waarschuwing | 13-01-2020

  8. 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

  9. Fast-Track Diagnostics FA-2019-19 - FTD Respiratory pathogens 21

    The purpose of this communication is to inform you of performance issues related to absence of validation and verification ...

    Waarschuwing | 19-12-2019

  10. bioMerieux SA FSCA 4592 - VIDAS VARICEL. ZOSTER IGG 60 T

    Er werd een onderzoek (PR#1663066) gestart naar aanleiding van klachten van klanten over een ongeldige kalibratie (relatieve ...

    Waarschuwing | 18-12-2019

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