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584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Stago, FSN-RC-21-0021, STA-R MAX

    FIELD SAFETY NOTICE Software version 4.06 on STA R Max®

    Waarschuwing | 17-06-2021

  2. CareDx AB, FSN-A-2021-091, Olerup QTYPE 11

    Urgent Field Safety Notice Olerup QTYPE 11 E047.

    Waarschuwing | 11-06-2021

  3. BioFire Diagnostics, LLC, FSN-FSCA 5183, PN plus Panel

    The purpose of this letter is to inform you that BioFire Diagnostics, LLC has identified a potential for elevated rates of false ...

    Waarschuwing | 10-06-2021

  4. Siemens Healthcare Diagnostics Inc., FSN-ASI 21-02, Atellica CH 930, IM 1300, IM 1600 Analyzers

    Siemens Healthcare Diagnostics has identified an issue with the Atellica Solution products.

    Waarschuwing | 01-06-2021

  5. Siemens Healthcare Diagnostics Inc., FSN-ASI 21-03, Atellica CH 930 Analyzer

    The purpose of this communication is to inform you of an issue with the product Atellica CH 930 Analyzer.

    Waarschuwing | 30-05-2021

  6. Roche Diagnostics GmbH, FSN-CN-593343 (SBN-RDS-CoreLab-2021-006), cobas® 6500 urine analyzer series (cobas u 701 microscopy analyzer in combination with cobas u 601 urine analyzer)

    Urgent Field Safety Notice cobas® 6500: possible sample mismatch software.

    Waarschuwing | 27-05-2021

  7. The Binding Site Group Limited, FSN-AE056, Freelite Human Kappa Free Kit on Roche Cobas

    Positieve bias met invloed op de kwaliteitscontroles van de Freelite Human Kappa Free Kit on Roche Cobas.

    Waarschuwing | 21-05-2021

  8. Randox Laboratories Ltd, FSN-REC527, Randox NEFA (Non-esterified fatty acid)

    Randox can confirm the NEFA standard 522FA packed within NEFA kit Catalogue Number FA115 Batch 544642 has been assigned ...

    Waarschuwing | 20-05-2021

  9. bioMerieux SA, FSN-FSCA 5173-1, MYLA®

    Urgent Product Correction Notice MYLA®

    Waarschuwing | 18-05-2021

  10. Siemens Healthcare Diagnostics Inc., FSN-CC 21-06, ADVIA Centaur Syphilis

    The purpose of this communication is to inform you of an issue with the product ADVIA Centaur Syphilis.

    Waarschuwing | 17-05-2021

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